>> GOOD AFTERNOON, EVERYONE.
WELCOME TO THE 68th MEETING OF
THE NATIONAL ADVISORY COUNCIL
FOR BIOMEDICAL IMAGING AND
BIOENGINEERING.
I'M ANNA TAYLOR, ASSOCIATE
DIRECTOR FOR RESEARCH
ADMINISTRATION, ACTING DEPUTY
DIRECTOR AND EXECUTIVE
SECRETARY.
I'D LIKE TO EXTEND A WARM
WELCOME TO FIVE NEW MEMBERS HERE
FOR THEIR FIRST OFFICIAL
MEETING.
THEY INCLUDE RAFAL WILBUR,
TYRONE, CHRISTINE, TAMARA, WE'RE
SLIGHTED YOU'RE ON BOARD
OFFICIALLY.
WE ALSO HAVE A COUPLE OF
DEPARTING MEMBERS, FAMILIAR
FACES.
TEJAL AND RAFAEL'S OFFICIAL
TERMS RUN IN JULY THEY HAVE
GRACIOUSLY AGREED TO EXTEND
THROUGH FEBRUARY OF 2026 PENDING
APPROVAL.
AND FOR THOSE WONDERING WHY
RAFAEL IS HERE, FIRST AND LAST
MEETING, BROUGHT ON BOARD TO
COMPLETE A TERM WHEN RECRUITED,
SO ON BEHALF OF BRUCE, NIBIB,
AND COMMUNITY WE SUPPORT I WANT
TO THANK YOU BOTH FOR YOUR
SERVICE.
WE HOPE TO SEE YOU IN PERSON IN
SEPTEMBER.
SO WITHOUT FURTHER ADO LET'S GET
STARTED WITH A FEW POINTS OF
ORDER.
REMINDER, THIS PORTION OF THE
MEETING IS OPEN TO THE PUBLIC
AND IS BEING LIVE BROADCAST AND
ARCHIVED.
TODAY'S MEETING IS HELD
VIRTUALLY, PRESENTERS ARE
PARTICIPATING IN TEAMS VIDEO
CONFERENCE.
LATER IN THE DAY WE'LL HAVE
CLOSED SESSION FOR THE REVIEW OF
PENDING GRANT APPLICATIONS.
MEMBERS OF THE PUBLIC WHO WISH
TO EXPRESS VIEWS REGARDING ANY
OF THE ITEMS WE DISCUSS DURING
THIS MEETING MAY DO SO IN
WRITING WITHIN THE NEXT TEN DAYS
BY E-MAILING ME AT
INFO@NIBIB.NIH.GOV.
AGAIN, INFO@NIBIB.NIH.GOV.
NIBIB COUNCIL IN THE SUBJECT
LINE OF THE E-MAIL.
A FEW REMINDERS FOR THOSE ON
TEAMS, PLEASE MUTE YOURSELF IF
NOT SPEAKING.
FOR THOSE PRESENTING, PLEASE
TURN ON YOUR CAMERA WHEN
PRESENTING, TURN OFF VPN SO WHEN
YOU SHARE SLIDES FROM THE LOCAL
FILE.
WHEN WE HAVE A PRESENTER SHARING
SLIDES, WE ASK THAT YOU TURN OFF
YOUR CAMERA TO PRESERVE
BANDWIDTH AND AT THE BEGINNING
OF THE Q&A YOU CAN TURN YOUR
CAMERAS BACK ON.
IF YOU HAVE TECHNICAL
DIFFICULTIES, REACH OUT TO
SUPPORT.
WE HAVE A TEAM OF PEOPLE
STANDING BY TO PROVIDE
ASSISTANCE.
WE HAVE DISABLED CHAT AND
REACTION FUNCTIONS FOR THIS
MEETING.
AND BEFORE WE GET STARTED DOES
ANYBODY HAVE ANY QUESTIONS?
OKAY.
HEARING NONE, I'D LIKE TO NOTE
FOR THE RECORD WE HAVE A QUORUM
FOR TODAY'S MEETING.
ALL OF OUR EX OFFICIOS ARE HERE,
SAVE ONE, DR. HO IS ABSENT
TODAY.
REMINDER THESE PROCEEDINGS ARE
GOVERNED BY FEDERAL ADVISORY
COMMITTEE ACT, FACA, GOVERNMENT
IN THE SUNSHINE ACT.
THEREFORE, THIS MEETING IS
ANNOUNCED TO THE PUBLIC, FEDERAL
REGISTER, CONSISTS OF A PORTION
OPEN TO THE PUBLIC AND A PORTION
CLOSED FOR DISCUSSION FOR
APPLICATIONS.
WE ANTICIPATE ENDING OPEN
SESSION ROUGHLY AT 3:30.
WE'LL SEE HOW THAT GOES.
YOU SHOULD SEE FUTURE COUNCIL
MEETING DATES IN THE ECB.
PLEASE REVIEW THESE DATES WHEN
YOU HAVE A MINUTE AND LET ME
KNOW IF YOU SEE CONFLICTS FOR
THOSE DATES BUT AS BRUCE
MENTIONED WE'RE HOPING TO HAVE
OUR NEXT MEETING IN PERSON IN
SEPTEMBER ON THE 16th.
SO, WE HOPE TO SEE YOU ALL HERE.
BEFORE WE GET INTO A
PRESENTATION THIS AFTERNOON, WE
HAVE A FEW HOUSEKEEPING ITEMS.
FIRST OF THESE IS A VOTE ON THE
MINUTES FROM OUR SEPTEMBER
MEETING WHICH WERE MADE
AVAILABLE TO YOU IN THE ECB.
SO IN PREPARATION FOR VOTING I
ASK COUNCIL MEANS TO PLEASE
UNMUTE YOURSELF FOR THE VOTE.
AND UNLESS ANYONE HAS ANY
COMMENTS OR QUALIFICATIONS I
WOULD ENTERTAIN A MOTION TO
APPROVE THE MINUTES.
>> SO MOVED.
>> SECOND?
>> SECOND.
>> AL THOSE IN AGREEMENT SAY
AYE.
>> AYE.
>> ANY OPPOSED SAY NAY.
CONGRATULATIONS, WE PASSED OUR
FIRST MOTION TODAY.
THANK YOU.
NOW THAT WE'RE WARMED UP, WE'RE
GOING TO MOVE TO THE COUNCIL
OPERATING PROCEDURES WHICH ARE
REQUIRED TO VOTE ON ANNUALLY.
SHOULD HAVE VOTED IN JANUARY BUT
WE'LL VOTE ON THEM TODAY.
THESE OPERATING PROCEDURES ARE
THE GROUND RULES FOR HOW NIBIB
INTERACTS WITH YOU, THE COUNCIL,
OUTLINES ACTIONS WE BRING BEFORE
YOU AND THOSE WE CAN TAKE
INDEPENDENTLY WITHOUT YOUR
APPROVAL.
LIKE THE MINUTES THE COUNCIL
OPERATING PROCEDURES WERE MADE
AVAILABLE IN THE ECB, AND WE DID
MAKE ONE MINOR CHANGE IN THE
OPERATING PROCEDURES.
THE CHANGE PERMITS US TO SEND AS
EARLY CONCURRENCE A BROADER
RANGE OF APPLICATIONS FOR YOUR
CONSIDERATION.
PREVIOUSLY DID NOT SEND
APPLICATIONS THROUGH THE
CONCURRENCE PROCESS, INCLUDING
THINGS LIKE ANIMAL OR HUMAN
SUBJECTS CONCERNS.
HOWEVER, NIH STAFF ARE REQUIRED
TO RESOLVE THESE CONCERNS PRIOR
TO MAKING AN AWARD, WE THOUGHT
THIS WOULD BE A REASONABLE
CHANGE AND MAY HAVE THE ADDED
BENEFIT ALLOWING US TO EXPEDITE
THE AWARD OF MORE APPLICATIONS.
DOES ANYBODY HAVE QUESTIONS OR
ANY OTHER COMMENTS THAT YOU
WOULD LIKE TO MAKE ON THE
OPERATING PROCEDURES?
HEARING NONE, ENTERTAIN A MOTION
TO APPROVE.
>> SO MOVED.
>> JOYCE IS ON FIRE TODAY.
SECOND?
>> SECOND.
>> ALL OPPOSED?
I SHOULD SAY ALL IN FAVOR,
EXCUSE ME.
>> AYE.
>> ANY OPPOSED?
THANK YOU FOR THE APPROVAL OF
THE OPERATING PROCEDURES.
LASTLY, BEFORE WE GET TO TODAY'S
MAIN EVENT WE'LL CONSIDER THE
INCLUSION REPORT, WE SHARED THIS
WITH YOU BY E-MAIL AS PART OF
EARLY CONCURRENCE PROCESS AS
WELL AS ECB, HOWEVER WE RECEIVED
CLARIFICATION IN REQUIREMENTS
SUCH THAT BE CONSIDERED IN OPEN
SESSION.
THIS IS A REQUIRED PERIODIC
REPORT, EVERY THREE YEARS,
DETAILING NIBIB'S COMPLIANCE
WITH NIH POLICIES OF THE
INCLUSION OF WOMEN AND
MINORITIES IN STUDY POPULATIONS
I'D LIKE TO THANK THOSE WHO
PREPARED THE REPORT AND
CHRISTINE COOPER FOR ENSURING
COMPLIANCE WITH SECTION 508 OF
THE REHABILITATION ACT OF 1973,
WHICH MAKES MATERIALS PRODUCED
BY THE FEDERAL GOVERNMENT
ACCESSIBLE FOR PEOPLE.
I DIDN'T HEAR ANY COMMENTS FROM
YOU IN ADVANCE OF THE MEETING.
BUT I'LL TAKE A MOMENT IN CASE
ANYBODY HAS ANY.
OKAY.
HEARING NO COMMENTS AT THIS
POINT I WILL TURN OVER THE
MEETING TO BRUCE FOR HIS UPDATE.
>> THANKS, ANNA.
I WILL LAUNCH MY SLIDES.
HOPEFULLY EVERYBODY CAN SEE
THAT.
THANKS FOR GOING OVER THOSE
THINGS.
SOME THINGS HAVEN'T CHANGED,
OTHERS HAVE.
WE'LL GO THROUGH THEM IN THE
DIRECTOR'S REPORT.
I FEEL LIKE THE NARRATOR FOR A
CONTINUING TV SERIES, YOU KNOW,
THAT STARTS OUT WITH PREVIOUSLY
ON NIBIB COUNSEL ... WE JUMPED
ON 15 MINUTES OR 10 MINUTES
BEFORE THE START AND SAID, WELL,
THERE'S A NEW ADMINISTRATION, WE
DON'T REALLY KNOW THAT MUCH,
BUT, YOU KNOW, THINGS ARE
CHANGING.
THAT USUALLY HAPPENS IN
ADMINISTRATIONS.
SO THAT WAS THAT MESSAGE THEN
AND WE LEARNED A LOT MORE NOW.
WE'LL BE SHARING WITH YOU KIND
OF THE BIG PICTURE ISSUES OF
MANY OF THE THINGS THAT HAVE
CHANGED.
BUT I ENCOURAGE YOU TO REACH OUT
TO US, NIBIB PROGRAM OFFICERS,
LEADERSHIP, AND SO FORTH,
BECAUSE YOU'RE GOING TO HAVE A
LOT OF QUESTIONS, AND WE
PROBABLY WON'T BE ABLE TO GET TO
ANSWER THEM FOR VARIOUS REASONS,
ALL OF THEM DURING THIS REPORT.
SO, WE ENCOURAGE YOU, WE REALLY
APPRECIATE YOUR INSIGHTS AND
GUIDANCE AND MORE THAN EVER I
THINK RIGHT NOW, BUT ALSO HAVING
AS FULL AN UNDERSTANDING OF MANY
OF THE CHANGES THAT ARE GOING ON
ACROSS THE NIH, AND ACROSS
FEDERAL AGENCIES, IT IS
EXTREMELY IMPORTANT IN GENERAL
FOR OUR SCIENTIFIC COMMUNITY, SO
WE'LL DO OUR BEST TO HELP SHARE
THOSE INSIGHTS WITH YOU THROUGH
A VARIETY OF CHANNELS AND IF YOU
HAVE QUESTIONS ABOUT THAT, DON'T
HESITATE TO CALL OR TEXT ME OR
ANY OF US HERE.
WE'RE VERY EAGER TO TALK TO YOU
MORE.
JUST STARTING OFF, YOU KNOW, I
ALWAYS REALLY LIKE TO
ACKNOWLEDGE OUR COUNCIL
ORGANIZATION, THEIR EFFORTS, TO
BRING ALL OF THIS TOGETHER.
IT'S REALLY EVEN MORE
CHALLENGING WHEN IT'S IN PERSON.
AND WE'RE GOING TO HAVE
HOPEFULLY ANOTHER ONE OF THOSE
AND THE SLIDE TEAM, ASHA,
KHALIL, IMMENSELY PRODUCTIVE AND
HELPFUL.
THIS PROCESS BRINGS OUR ENTIRE
INSTITUTE TOGETHER HAS EVERYBODY
PUTS SLIDES TOGETHER THEY WANT
TO BE PRESENTED AND DISCUSSED,
AND SO, YOU KNOW, LEGEND HAS IT
THAT WE SCHEDULE ABOUT A
ONE-HOUR MEETING TO GO OVER
THOSE, MAYBE AN HOUR-AND-A-HALF,
AND I MAKE IT GO THREE HOURS.
BUT I DON'T KNOW IF I CAN EVER
BRING IT IN UNDER TIME.
BUT IT'S JUST A REALLY GREAT
CHANCE FOR US TO COMMUNICATE AND
SHARE INFORMATION.
OF COURSE OUR SENIOR LEADERSHIP
TEAM, ANNA JUST -- WELL, NOT
RECENTLY JOINING, IT'S BEEN
SEVERAL MONTHS NOW, CHRIS, MANU,
KRIS, RICHARD.
I HAVE ANNOUNCEMENTS.
FIRST OF ALL, PAM IS RETIRING.
AND SHE HAS WORKED AT NIBIB
SINCE 2006, JUST A FEW YEARS
AFTER WE WERE ESTABLISHED.
AND WHEN I JOINED COUNCIL, PAM
WAS THE FIRST PERSON WHO I
STARTED TO WORK WITH AND MADE MY
LIFE JUST SO MUCH SIMPLER AND
HELPED ME THROUGH SO MANY
THINGS.
I COULD TALK A BIT ABOUT PAM BUT
I WANT TO TALK -- PASS IT OVER
TO DAVE AND ANNA WHO WILL HAVE
SOME REFLECTIONS ABOUT PAM.
>> WELL, I WILL JUST -- I LET
DAVE SAY THE MOST BECAUSE HE
WORKED WITH PAM THE MOST BUT I
THINK PAM IS PROBABLY THE PERSON
A THE NIBIB BESIDES BRUCE
COUNCIL MEMBERS KNOW THE BEST.
AND I THINK THAT, YOU KNOW, I
FIRST MENTIONED SHE'S THE PERSON
THAT HELPS PUT ALL OF THIS
TOGETHER AND MAKES YOUR LIVES
EASIER, MINE AS WELL.
I DON'T HAVE TO WORRY ABOUT
THINGS NOT GETTING DONE BECAUSE
IRKNOW BETWEEN PAM AND AISHA,
THEY HAVE IT COVERED.
IT'S WONDERFUL TO NOT HAVE TO
QUESTION WHETHER OR NOT THINGS
WILL BE SMOOTH.
SO, I REALLY APPRECIATE YOU,
PAM, FOR ALL YOU'VE DONE SINCE
I'VE BEEN HERE.
I WISH YOU NOTHING BUT THE BEST
IN RETIREMENT AND I HOME THAT
EVEN THOUGH YOU'RE RETIRED YOU
STILL BRING OCCASIONAL BRISKET
BECAUSE PAM MAKES DELICIOUS
BRISKET.
SO, CONGRATULATIONS, PAM.
AND WISHING YOU NOTHING BUT THE
BEST.
DAVID?
>> THAT WAS BEAUTIFUL, I WOULD
HAVE MADE ALL THOSE POINTS.
I REALLY HAVE NOTHING TO ADD.
I HAD THE PLEASURE OF WORKING
FOR, WITH PAM IN 2006 WHEN SHE
WAS IN REVIEW FOR A LITTLE
WHILE, DEPARTED NIBIB AND
RETURNED TO BE THE COMMITTEE
MANAGING OFFICER, AND I
CONTINUED TO WORK WITH HER.
ONE OF THE ANCHORS OF THE
INSTITUTE, AND A LONG WITH
ALICIA TOO, THEY ARE SUCH A TEAM
FOR US HERE.
COUNCIL RUNS VERY SMOOTHLY.
IT'S ORGANIZED ON ACCOUNT OF HER
STRENGTH AND HER EFFORTS, AND
ANNA MENTIONED THE BRISKET, AND
WHEN PAM CAME A COUPLE OR THREE
WEEKS AGO AND LET US KNOW SHE
WAS GOING TO RETIRE SHE DID
MITIGATE THE SHORT-TERM PAIN BY
DELIVERING IT WITH BRISKET, THE
MESSAGE.
SO THANK YOU SO MUCH, PAM.
WISHING YOU THE BEST, A LONG,
HAPPY, HEALTHY RETIREMENT.
AND THANK YOU SO MUCH.
>> THANK YOU.
>> AND, YOU KNOW, I JUST WANT TO
ACKNOWLEDGE THAT THIS IS
PROBABLY EMBARRASSING PAM, I
DON'T FEEL BAD FOR THAT AT ALL.
>> I'LL GET YOU BACK.
>> I'M SURE YOU WILL.
THANKS, PAM.
DO YOU WANT TO SAY ANYTHING?
>> NO.
JUST THANKS, EVERYONE, FOR
PUTTING UP WITH MY NAGGING.
>> WELL, AS COUNCIL MEMBERS WILL
SEE, THOSE IN THE VIDEOCAST AND
EVERYONE WHO PARTICIPATED, THIS
IS KIND OF A THEME OF THIS
DIRECTOR'S REPORT.
AS YOU READ IN THE PRESS, THERE
HAVE BEEN MANY PERSONNEL CHANGS
ACROSS AGENCIES, HHS IN
PARTICULAR, NIH, CERTAINLY NIBIB
HAS BEEN NO EXCEPTION.
MOVING TO ANOTHER RETIREMENT,
JILL HUGHES KIRK HAS BEEN BEEN
SO IMPACTFUL, PLAYED SUCH AN
ESSENTIAL ROLE AT DEPUTY
DIRECTOR SINCE 2016, CO-LED
RADX-TECH PROGRAM, LED
ACCESSIBILITY COMPONENT,
TRANSFORMED -- HELPED TRANSFORM
ACCESSIBLE DESIGN FOR POINT OF
CARE AND MAXIMUM TECHNOLOGIES.
SHE PREVIOUSLY HAD LEADERSHIP
POSITIONS, WE WERE FORTUNATE TO
GET HER AT NIMH, AND NINDS, SO I
WAS A COUNCIL MEMBER WHEN SHE
FIRST JOINED NIBIB, AND GETTING
TO KNOW HER AND DAVE, AND
ACTUALLY EVERYONE AT NIBIB, LONG
TIME CONNECTIONS WITH THE
PROGRAM FOLKS, THAT GAVE ME
CONFIDENCE TO COME HERE.
SUCH AMAZING PEOPLE.
JILL HAS BEEN AT THE TIP OF THAT
SPEAR FOR SO LONG, SHE WAS
FOUNDER OF THE NIH BLUEPRINT OF
THERAPEUTICS NETWORK, SERVED ON
MULTIPLE ADVISORY BOARDS IN
NEUROSCIENCE, HER BACKGROUND,
Ph.D. IN BIOCHEMISTRY AND
BIOPHYSICS FROM UCSF, BUT WE
TEASED HER THROUGHOUT ABOUT IF
WE COULD GRANT DEGREES WE WOULD
GIVE HER A Ph.D. IN BIOMEDICAL
ENGINEERING.
SHE'S DONE ALL OF THAT WORK, AND
THE ADDITIONAL DIMENSIONS OF
UNDERSTANDING POLICY, STRATEGY,
HELPING US NAVIGATE THROUGH THE
COMPLEXITY OF ALL THE THINGS
HAPPENING IN GOVERNMENT.
SO, JILL HAD PLANNED THIS.
SO IT'S JUST REST ASSURED THIS
IS SOMETHING SHE HAD BEEN
TARGETING.
AND OF COURSE YOU MET ANNA
ALREADY.
AND SHE TRULY HAS TAKEN THIS
ROLE ON AND WE'RE SO GLAD TO
HAVE HER, ALSO FROM
NEUROSCIENCE, THERE'S A PATTERN
HERE.
AND, YOU KNOW, OUTSTANDING
NEUROSCIENTIST, FORMER AAAS
SCIENCE AND TECHNOLOGY FELLOW
AND WILL INVOKE THAT EXPERTISE
IN A FEW SLIDES HELPING ME
UNDERSTAND A LOT OF THE POLICY
IMPLICATIONS, SHE'S A POLICY
PRO, WE'RE GLAD TO HAVE HER JOIN
US.
I SHOULD CLARIFY, SHE HAS THIS
ACTING DEPUTY DIRECTOR ROLE THAT
JILL HAD BEFORE, IN ADDITION TO
HER PERMANENT ROLE AS THE ORA
DIRECTOR, YOU'LL SEE IN THE
ORGANIZATIONAL CHART.
WE DIDN'T GET A CHANCE TO
ANNOUNCE IN JANUARY, SO WE'RE
REALLY FORTUNATE TO HAVE
PERMANENT POSITIONS FOR OUR TEAM
WHO WERE IN ACTING POSITIONS.
THIS IS A CHALLENGE TO GET SORT
OF THOSE UPGRADES FROM ACTING TO
PERMANENT.
SOMEHOW WE -- MAYBE WE
ANTICIPATED THAT MIGHT BE
DIFFICULT, AND IN THE SORT OF
NEW YEAR, SO WE'RE FORTUNATE TO
GET THESE DONE, ANN GAWALT, AND
THIS ACCOMPANIED SORT OF IN --
MAYBE THIS IS IN THE DETAILED
WEEDS, BUT THIS POSITION FOR
NIBIB WAS UPGRADED TO A
SENIOR -- SES, SENIOR EXECUTIVE
SERVICE POSITION, SO WE'RE
REALLY EXCITED TO HAVE ANN AS
THE FIRST SES EXECUTIVE OFFICER
OF NIBIB.
AND DAVE RAMPULLA, DEPUTY
DIRECTOR OF EXTRAMURAL SCIENCE
PROGRAM, WORKING WITH ALL OF OUR
PROGRAM OFFICERS, REPORTING
DIRECTLY TO DAVE GEORGE.
AND REALLY HELPING EXTEND OUR
IMPACT AND INFLUENCE ACROSS THE
NIH.
AND BEHROUS SHABBESTARI HAS BEEN
ACTING DIRECTOR FOR MANY YEARS,
WELL KNOWN TO OUR EXTRAMURAL
COMMUNITY, ENORMOUSLY HELPFUL
AND THOUGHTFUL AND EXPERIENCED
IN STRATEGY, TECHNOLOGY, AND
REVIEW, JUST A WEALTH OF
EXPERIENCE SO REALLY GLAD TO
HAVE ALL OF THESE FOLKS IN
PERMANENT SENIOR LEADERSHIP
POSITIONS.
LAST YEAR WE WERE ABLE TO HIRE A
FEW NEW STAFF.
AND THEY HAVE BEEN RETAINED, SO
WE'RE REALLY EXCITED ABOUT THAT.
KEY AREAS OF NEED, SO ASHLEY IN
OFFICE OF GRANTS MANAGEMENT,
EMILY ALSO IN THAT OFFICE.
STACIE AND MOST NOTABLY FROM AN
INTERACTION POINT OF VIEW WHERE
COUNCIL AND OUR INVESTIGATORS
WILL BE INTERACTING WITH STACIEO
GUTOWSKI, EXPERIENCE WITH FDA,
VERY SKILLED IN UNDERSTANDING
THAT REGULATORY PROCESS AND
PARTNERSHIP SO I ENCOURAGE FOLS
TO REACH OUT TO HER, AND KRISTIN
GILCHRIST, ALSO A PROGRAM
OFFICER IN OUR DIVISION OF
TECHNOLOGY, A DISTINGUISHED
ACADEMIC WE'RE IN BIOMEDICAL
ENGINEERING AND RADIOLOGY,
JOINTLY APPOINTED, USES
UNIFORMED SERVICES UNIVERSITY
HEALTH SCIENCE SCHOOL, AND ALSO
AGAIN TRAINING Ph.D. AND
BIOMEDICAL ENGINEERING,
UNDERGRADUATE IN ELECTRICAL
ENGINEERING, VANDERBILT,
STANFORD, SO WE'RE JUST REALLY
GLAD AND EXCITED TO HAVE THEM
WITH US AS PROGRAM OFFICERS.
SO STAFF HAVE BEEN THROUGH A LOT
AS YOU HAVE BEEN HEARING ABOUT
IN THE PRESS I'M SURE.
I WANTED TO GIVE A BIG PICTURE
OVERVIEW OF THE IMPACT TO US.
WE'RE PRETTY SIMPLE
ORGANIZATIONALLY, FOUR MAJOR
OFFICERS OR PROGRAMS OR
DIVISION, ADMINISTRATIVE
MANAGEMENT, RESEARCH
ADMINISTRATION, EXTRAMURAL
SCIENCE PROGRAM WITH THE HIGHEST
HEAD COUNT WITH SPECIAL
DIVISIONS OF TECHNOLOGIES, AND
PROGRAM OFFICERS, AND THE
INTRAMURAL RESEARCH PROGRAM WITH
MULTIPLE LABS AND UNIQUE CORE
RESOURCES.
SO, TOTAL, AND THIS EXCLUDES
CONTRACTORS, THESE ARE JUST OUR
FTE ACCOUNTS, WE'VE HAD ABOUT
22% REDUCTION ACROSS NIBIB.
THE HEAD COUNT HAS GONE FROM 152
TO 118.
AND THESE ARE NOT ALL SETTLED,
SO SOME STILL MAY BE COMING
BACK, SOME STILL ON
ADMINISTRATIVE LEAVE.
SO HOPEFULLY WE'LL HAVE MORE
DEFINITIVE UPDATES FOR YOU IN
THE NEXT COUNCIL MEETING, BUT AS
YOU MIGHT EXPECT, THIS IS
SOMETHING THAT IS CHANGING.
IT SEEMS FROM WEEK TO WEEK OR
MONTH TO MONTH.
SO WE'RE HOPING TO GET SOME
STABILIZATION OF THIS AND WE'RE
ALSO HOPING TO GET MORE OF THESE
FOLKS RETURN.
IT'S A CONSTANT DISCUSSION AND
EFFORT.
MOST NOTABLY, AND FOR THOSE WHO
WORKED WITH OUR OFFICE OF
COMMUNICATIONS OR SCIENCE POLICY
AND COMMUNICATIONS, THE ENTIRE
OFFICE, SO THEY HAVE BEEN
WRITING, GETTING IN TOUCH WITH
YOU, HELPING COMMUNICATE OUR
COMMUNITY'S FINDINGS TO THE
PUBLIC, THE WEBSITE, ORGANIZING
INTERACTIONS WITH CONGRESS AND
SO FORTH.
ALL ACROSS THE NIH MOST OF THE
FOLKS WITHIN INSTITUTES HAVE
BEEN INVOLUNTARY SEPARATED BUT
THERE IS AN EFFORT TO BRING SOME
FRACTION BACK.
THEY MAY COME BACK INTO A LARGER
POOL OF COMMUNICATIONS THAT'S
CENTRALIZED.
WE DON'T KNOW THIS.
BUT OBVIOUSLY COMMUNICATING WHAT
WE DO AND IN PARTICULAR WHAT
NIBIB DOES, WHICH IS TOUGHER OF
A COMMUNICATION, HARDER, MORE
SPECIALIZED THAN OTHER
INSTITUTES.
IT'S SOMETHING WE ARE HELPING
EVERYONE ACROSS IN LEADERSHIP
ACROSS NIH AND HHS UNDERSTAND,
AND PROVIDES GREAT VALUE AND
OTHER DIMENSIONALITY TO THE
ORGANIZATION, SO IT'S AN
INCREDIBLY TALENTED TEAM AND
WE'RE WORKING HARD TO HOPEFULLY
HAVE THIS TEAM RESTORED BACK TO
THE NIH.
AND JUST, YOU KNOW, TO -- I
DON'T HAVE PICTURES OF EVERYONE.
I JUST WANTED TO SORT OF SHOW
THESE ARE KNOWN DEPARTING STAFF.
SOME MAY BE FAMILIAR WITH A FEW
OF THEM, IN PARTICULAR ALBERT
AVILA WHO LED OUR HBCU PROGRAM
TO DEVELOP BIOENGINEERING
PROGRAMS AT HBCU, LONGTIME
VETERAN OF THE NIH, AND SO WE
MISS ALBERT AND WE'RE HOPING --
YOU KNOW, HE'S LOOKING FOR OTHER
THINGS, BUT, YOU KNOW, WE'RE --
JUST TAKE A MOMENT TO REFLECT
AND MISS HIM AND JOHN HAYES, A
19-YEAR VETERAN, SCIENTIFIC
REVIEW OFFICER.
SO SOME OF YOU MAY HAVE
INTERACTED WITH ALBERT AND JOHN,
AND OTHERS, MANY OF OUR FOLKS
WE'VE LOST THAT ARE BEHIND THE
SCENES AND SO WE WANT TO THANK
THEM AND ACKNOWLEDGE THEIR
WONDERFUL CONTRIBUTIONS.
EVERYONE KNOW THIS IS BUT I WANT
TO REINFORCE WITH PICTURES, NIH
PICTURES, THE NIH DIRECTOR, JAY
BHATTACHARYA, PRIOR DIRECTED
STANFORD CENTER ON DEMOGRAPHY OF
HEALTH AND AGING, HIS RESEARCH,
Ph.D. IS IN ECONOMICS, SO
RESEARCH HAS BEEN ON THE
ECONOMICS OF HEALTH CARE,
EMPHASIS ON HEALTH OF VULNERABLE
POPULATIONS, A REVIEWERS, SPEAKS
ABOUT HIS PASSION AND EXPERIENCE
WITH THE NIH THROUGHOUT HIS
CAREER.
SO, JAY HAS BEEN GIVING LOTS OF
PRESENTATIONS AND TALKS TO SOME
OF THE INSTITUTES, WE'VE BEEN
MEETING WITH HIM ON A REGULAR
BASIS, ALL THE INSTITUTE
DIRECTORS, AND HE'S ALSO MET
WITH ALL THE DIRECTORS, ONE ON
ONE, AND HE'S NOW REALLY DEEPLY
ENGAGED IN CONGRESSIONAL BUDGET
SEASON, SO THE HEARINGS AND HE
WILL CONTINUE TO EXPAND THAT
EFFORT IN THE COMING WEEKS TO
GET SOME INSIGHTS INTO HIS
THOUGHTS AND PRIORITIES, NINDS
HAD A COUNCIL MEETING MAY 14.
AND ABOUT 30 MINUTES INTO THAT
VIDEOCAST, JAY COMES IN AND
APPEARS, GIVES A PRESENTATION,
ANSWERS QUESTIONS.
I ENCOURAGE EVERYONE TO TAKE A
LOOK AT THAT VIDEOCAST, TO HELP
UNDERSTAND WHAT HIS VISION IS.
HE HAS SEVERAL THINGS THAT ARE
TOP PRIORITIES, I'LL COME BACK
TO SOME OF THOSE AT THE END OF
MY PRESENTATION AND HOW THEY
ALIGN WITH WHAT OUR COMMUNITY
DOES.
AND THAT'S PART OF OUR
MESSAGING.
MY CONSTANT MESSAGING TO NIH
LEADERSHIP.
MATT MEMOLI STEPPED IN AS THE
ACTING NIH DIRECTOR IN BETWEEN
JAY'S FINALIZATION OF HIS
APPOINTMENT, AND SOME OF YOU MAY
KNOW HIS BACKGROUND IS
INFECTIOUS DISEASE, SO HE CAME
TO NIAID TO DO THIS IS
INFECTIOUS DISEASE FELLOWSHIP.
HE'S A PHYSICIAN.
AND HE PREVIOUSLY LED THE
CLINICAL STUDIES UNIT WITHIN THE
LABORATORY OF INFECTIOUS
DISEASE.
HIS RESEARCH IS IN INFLUENZA
TRANSMISSION, IMMUNITY, VACCINE
DEVELOPMENT, WHICH SOME OF YOU
MAY HAVE HEARD ABOUT ALREADY.
AND HE FOR THAT SORT OF
FEW-MONTH PERIOD BETWEEN JANUARY
AND MARCH HELPED WITH MANY ACUTE
PROBLEMS THAT CAME ABOUT AS A
RESULT OF THE NEW EXECUTIVE
ORDERS AND DID IT IN A VERY
DEDICATED AND TIRELESS WAY, AND
THROUGH HIS LEADERSHIP WE
WERE -- -- MANY FUNCTIONALITIES
THAT IMMEDIATELY STOPPED, MATT
TOOK ON THE RESPONSIBILITY TO
GET THEM ROLLING.
THAT'S BY DEFINITION ALMOST THE
ROLE OF THE DEPUTY DIRECTOR OF
THE NIH, THE PROBLEM SOLVER, THE
PERSON WHO WORKS OUT THE
DETAILS.
AND MAKES THE ARGUMENTS AND THE
DEALS AND THE SORT OF PRACTICAL
CONSIDERATIONS WITH HHS
LEADERSHIP AND WHITE HOUSE
LEADERSHIP.
SO MATT TRIED ALL OF THAT OUT,
TRIAL BY FIRE FOR A FEW MONTHS,
AND DEVELOPED UNIQUE SKILLS IN
THAT REGARD IN THIS INTENSE
EXPERIENCE, AND HE HAS NOW
TRANSITIONED TO THE PRINCIPAL
DEPUTY DIRECTOR OF NIH.
SO, MANY OF YOU HAVE ALSO BEEN
FOLLOWING SOME SENIOR LEADERSHIP
DEPARTURES.
YOU KNOW, THE SEGUE FROM MATT IS
TO LARRY TABAK.
THEY OVERLAPPED FOR SEVERAL
WEEKS.
DR. TABAK, THE ENORMOUSLY
TALENTED AND LONG-SEARCHING
PRINCIPAL DEPUTY DIRECTOR,
REALLY SEEN NIH AND CONTRIBUTED
TO NIH FROM THE GROUND FLOOR
FROM HIS LABORATORY TO
LEADERSHIP ON NIDCR, PRINCIPAL
DEPUTY DIRECTOR, AND HE STEPPED
DOWN JUST I THINK IN MARCH I
BELIEVE.
TARA SCHWETZ, DEPUTY DIRECTOR
FOR PROGRAM COORDINATION,
DPCPSI, THAT'S IN THE OFFICE OF
THE DIRECTOR, HAS STEPPED DOWN.
MIKE LAUER, MANY FAMILIAR WITH
MIKE, DEPUTY DIRECTOR FOR OFFICE
OF EXTRAMURAL RESEARCH,
LONG-SERVING, INNOVATIVE AND
TALENTED.
THESE FOLKS DEFINED THOSE ROLES
AS DID JOHN BURKLOW, 40-YEAR
SERVICE AT THE NIH, AS THE CHIEF
OF STAFF FOR PROBABLY ABOUT
HALF, ROUGHLY HALF OF THAT TIME.
AND EXTRAORDINARY COMMUNICATOR
AND PROBLEM SOLVER AND LIZA
BUNDESEN, DEPUTY DIRECTOR AT
OER.
THIS IS THE LOSS OF INCREDIBLE
LONGTIME HIGHLY SKILLED TALENT
IN LEADERSHIP POSITIONS ACROSS
THE NIH.
SO SOME TRANSITIONS TO COME IN,
FIRST THE CHIEF OPERATING
OFFICER, ERIC, THIS IS A NEW
POSITION, BACKGROUND IS IN
DoD, IN PARTICULAR HIS
INTERESTS ARE IN ORGANIZATION
MANAGEMENT AND SECURITY, AND
HE'S BEEN ACTUALLY QUITE A
STRONG DEFENDER AND VERY
EFFECTIVE IN HELPING US GET
OPERATIONAL ISSUES MOVING AGAIN.
AND SO WE WELCOME HIM ON BOARD.
SEANA CRANSTON HAD SIGNIFICANT
LEGISLATIVE EXPERIENCE AS AN
AIDE TO A COUPLE MEMBERS OF
CONGRESS, SO SHE'S COME ON
BOARD.
BOTH OF THEM WERE ABLE TO
OVERLAP A BIT WITH JOHN BURKLOW,
SO THAT WAS EXTREMELY IMPORTANT
HELPING THEM UNDERSTAND ASPECTS
OF THE POSITION BECAUSE NEITHER
HAS EXPERIENCE, PRIOR
EXPERIENCE, IN WORKING AT NIH OR
IN THE SCIENCE AGENCY LIKE WE
ARE.
JAMES McELROY, WHO HAS COME ON
AS THE DEPUTY CHIEF OF STAFF.
YOU KNOW, AGAIN, NO PRIOR NIH
EXPERIENCE BUT CERTAINLY HE'S
NOW MET WITH ALL OF THE
INSTITUTE DIRECTORS, DEPUTY
DIRECTORS, HE'S REALLY COMING UP
TO SPEED ON OUR MISSION AND THE
DETAILS OF WHAT EACH INSTITUTE
DOES.
SO JON LORSCH, MANY OF YOU KNOW
HE'S THE DIRECTOR OF NIGMS, AND
HE HAS STEPPED INTO THE ROLE,
VERY CHALLENGING POSITION, AS
THE ACTING DEPUTY DIRECTOR FOR
EXTRAMURAL RESEARCH, OER, SO
MIKE LAUER'S POSITION, DO AN
INCREDIBLE JOB WORKING ACROSS
MULTIPLE INSTITUTES ON A VERY
COMPLICATED TASK OF TRYING TO
UNDERSTAND AND RESOLVE THE
ADMINISTRATION PRIORITIES WITH
OUR ACTIONS.
AND THIS IS AN ONGOING ACTIVITY,
HIS COLLEAGUE RAY JACK JACOBSOS
ACTING DEPUTY DIRECTOR, AND TO
STEP INTO TARA'S ROYAL NICOLE
KLEINSTREUER, BIOMEDICAL
ENGINEERING, BIOMEDICAL
COMPUTATION, STEPPED INTO THE
ACTING POSITION OF DEPUTY
DIRECTOR FOR PROGRAM
COORDINATION, PLANNING,
STRATEGIC INITIATIVES.
OKAY.
IF YOU'RE NOT EXHAUSTED ENOUGH I
HAVEN'T -- I'M JUST BEGINNING,
WARMING UP A LITTLE.
SO THERE'S BEEN SEVEN INSTITUTE
AND CENTER DIRECTORS WHO HAVE
BEEN ASKED TO LEAVE THEIR
POSITIONS OR THEY HAVE BEEN
GIVEN CHOICES BUT, YOU KNOW,
THIS IS SORT OF THE NET RESULT.
JEANNE MARRAZZO, KIM RATHMELL
FROM NCI, DR. BIANCHI FROM
NICHD, ERIC GREENE FROM NHGRI,
ELISEO PEREZ-STABLE, SHANNON
ZENC AND KATHLEEN NEUZIL,
SHOCKING, HAPPENED IN A PERIOD
OF ONE DAY, OR ONE AND A HALF
DAYS.
AND FORTUNATELY WE HAVE AN
EXTRAORDINARY GROUP OF TALENTED
DEPUTY DIRECTORS AND PEOPLE WHO
ARE REALLY SKILLED AND ABLE TO
STEP INTO LEADERSHIP POSITIONS
SO JEFF TAUBENBERGER STEPPED IN,
DOUG LOWY, IF YOU ADD HIS ACTING
DIRECTOR STINTS HE'S PROBABLY
SERVED LONGER THAN ANY NCI
DIRECTOR.
ALISON CERNICH, CAROLYN HUTTER,
MONICA WEBB HOOPER, COURTNEY
AKLIN, AND PETER KILL KILMARX AT
THE FOGARTY, BEGINNING TO
STABILIZE, OVER THE LAST COUPLE
WEEKS, ALL INTEGRATED WITH NIH
LEADERSHIP.
TO SUMMARIZE THE CHANGES THAT
ARE CURRENT AND ON THE HORIZON,
YOU'VE ALL HEARD THERE ARE
ADMINISTRATIVE PRIORITIES.
WHAT'S THE NET RESULT HERE?
AND I'M GIVING SORT OF A BIG
PICTURE VIEW.
YOU SHOULD REACH OUT TO PROGRAM
OFFICERS, REACH OUT TO US, TO
UNDERSTAND DETAILS OF EACH OF
THESE.
BUT FIRST OF ALL THERE ARE AWARD
HOLDS AND TERMINATIONS, THESE
ARE ONGOING.
SOME OF OUR NOTICES OF FUNDING
OPPORTUNITIES, NOFOs, HAVE
BEEN TAKEN DOWN.
OTHERS HAVE BEEN UPDATED AND
REPOSTED.
BUT REALLY FUNDAMENTALLY THERE
WILL BE A NEW NOFO REVIEW AND
FORECASTING PROCESS, RAMPING UP
RIGHT NOW.
AND IN GENERAL THERE WILL BE A
REDUCTION IN NOTICES OF FUNDING
OPPORTUNITIES, BUT THAT'S SORT
OF VERY BIG PICTURE COMMENT.
TRYING TO SORT OF THIN THIS OUT,
AND THEN OTHER PROCESSES LIKE
PERHAPS POSTING ON OUR WEBSITES,
WILL SORT OF FILL IN GAPS WHERE
WE MAY NOT HAVE EXTENSIVE A
PUBLICATION PROCESS.
SECOND MAJOR THEME THAT PERHAPS
MANY OF YOU ARE VERY FAMILIAR
WITH AND MAY BE IMPACTED BY THE
FOREIGN SUBAWARDS HAVE BEEN
PAUSED.
AND THERE IS UNDER DEVELOPMENT A
NEW MECHANISM TO TRACK FUNDS,
THIS IS AN ONGOING PROCESS.
HOPEFULLY IT WILL BE A FAST
ONGOING PROCESS.
AND, AGAIN, WE CAN UPDATE IN
MORE DETAIL A LITTLE BIT OF
THAT.
AND THEN OF COURSE AS I'VE
ALLUDED TO, REALLY FROM THE
BEGINNING OF THIS PRESENTATION,
WE'VE HAD PRETTY SIGNIFICANT
STAFFING REDUCTIONS, 34 PEOPLE
HERE, 22% OF OUR STAFF.
I DON'T KNOW WHAT THE
PERCENTAGES ARE EXACTLY AT ALL
THE OTHER INSTITUTES BUT THEY
ARE COMPARABLE.
SO THESE ARE PRETTY LARGE
NUMBERS.
PROBATIONARY EMPLOYEES, RIFs,
VOLUNTARY, EARLY, ON TIME,
RESIGNATIONS, SOME MADE IT INTO
POLICY UPDATES.
SO, THE PREVIOUS SLIDE WAS ABOUT
SORT OF THE BIG PICTURE CHANGES
THAT ARE -- THAT WERE
INTRODUCED, THAT ARE ONGOING.
THESE ARE DETAILED INSTRUCTIONS.
AS I MENTIONED BEFORE, I'M THE
POLICY AMATEUR SO I TURN IT OVER
TO ANNA, A POLICY PRO, TO GIVE
HER PERSPECTIVE AND
INTERPRETATION OF THESE.
AND YOU SHOULD ALL HAVE THE
SLIDE DECK.
THERE'S A PDF FILE WITH THE
LINKS TO THIS SO YOU CAN FOLLOW
UP.
ANNA, I'LL TURN IT OVER TO YOU
FOR A BIT.
>> THANKS.
I THINK ONE OF THE REASONS WE
WANTED TO PUT OUT THIS
INFORMATION, THINGS ARE CHANGING
RAPIDLY, AS I'M SURE YOU'VE ALL
CAUGHT ON TO.
AND SO IT'S HARD TO KEEP TRACK
OF EVERYTHING THAT'S HAPPENING.
WE WANTED TO KIND OF GIVE YOU A
COMPREHENSIVE LOOK AT SOME
CHANGES SO YOU CAN HELP
DISSEMINATE THAT INFORMATION TO
YOUR COLLEAGUES AND, YOU KNOW,
SHARE WITH OTHERS.
SO, AS YOU KNOW, EARLY ON, THERE
WAS A POLICY NOTICE ISSUED TO
REDUCE INDIRECT COST RATE, 15%
FOR INSTITUTIONS ACROSS THE
COUNTRY.
THIS IS CURRENTLY ON HOLD.
WE WILL -- WE'RE CURRENTLY
ISSUING AWARDS AT PREVIOUSLY
NEGOTIATED RATES, EXCEPT FOR
THOSE THINGS LIKE FELLOWSHIPS,
TRAINING.
SO, AS BRUCE MENTIONED, THERE'S
MORE TO COME ON FOREIGN
SUBAWARDS BUT ONE OF THE THINGS
THAT CAME OUT RECENTLY WAS A
REMINDER THAT IF A PROJECT
INCLUDES ACTIVITIES OUTSIDE THE
U.S., YOU SHOULD INCLUDE FOREIGN
JUSTIFICATION WITH THAT
APPLICATION BECAUSE IN POLICY
THAT IS A REQUIREMENT BUT IT
HASN'T NECESSARILY BEEN
ENFORCED.
AS YOU'RE AWARE, NIH HAS BEEN
KIND OF AT A PROVISION TO PUBLIC
ACCESS POLICY FOR QUITE SOME
TIME, HAS PLANS TO UPDATE PUBLIC
ACCESS POLICY IN DECEMBER, ONE
OF THE FIRST THINGS DR.
BHATTACHARYA DID WAS ACCELERATE
THE DATE TO JULY 1, BASICALLY
STATES THAT ANY PUBLICATIONS
ACCEPTED FOR PUBLICATION, MADE
PUBLICLY AVAILABLE IMMEDIATELY
WITHOUT EMBARGO UPON THE
OFFICIAL DAY OF PUBLICATION, CAN
DO THAT THROUGH PUBMED CENTRAL
IF YOUR JOURNAL DOESN'T SUPPORT
THAT.
REGARDING FOREIGN SUBAWARDS, A
NEW FOREIGN COLLABORATION
STRUCTURE FOR SUBAWARDS, THAT
WILL BE RELEASED LATER IN THE
YEAR BUT UNTIL IT'S TIME, IT'S
STILL UNCLEAR.
THERE'S A TEMPORARY LIMITATION
ON ABILITY FOR INVESTIGATORS OR
INSTITUTIONS TO REQUEST
EXTENSIONS, PRIOR APPROVAL
REQUEST IN ERA COMMONS.
A RECENT EXECUTIVE ORDER ON
PROHIBITING SUPPORT OF GAIN OF
FUNCTION RESEARCH, NIH IS NO
LONGER ACCEPTING APPLICATIONS ON
THIS TYPE OF RESEARCH AND WILL
SUSPEND ONGOING RESEARCH IN
THESE ACTIVITIES.
WE'RE NOT QUITE SURE WHAT THE
IMPLEMENTATION WILL LOOK LIKE,
HAVE NOT RECEIVED A LOT OF
GUIDANCE, TAKE A LOOK AT THAT.
SOME GOOD THINGS ARE HAPPENING
TO, BECAUSE THERE'S DELAYS WE
SAW EARLY ON, THERE'S AN
AUTOMATIC EXTENSION OF ESI
ELIGIBILITY TO MITIGATE,
DEPENDING HOW MUCH TIME YOU HAVE
LEFT IN YOUR ELIGIBILITY WINDOW,
YOU CAN GET UP TO THREE CYCLES
OF EXTENSION.
SO THERE'S MORE DETAILS
FOLLOWING THAT NEWS.
AND WHAT'S NOT IN THAT NEWS,
WORTH NOTING, IS THAT AS BRUCE
MENTIONED THERE ARE AWARDS THAT
HAVE BEEN TERMINATED, IN AWARD
HAS BEEN ENDED PREMATURELY TO AN
INVESTIGATOR THEY ARE ABLE TO
SUBMIT AN EXTENSION REQUEST
THROUGH REGULAR EFI EXTENSION
REQUEST PROCESS, AND THAT'S --
THOSE ARE UNDER CONSIDERATION.
SO IF YOU'RE AWARE OF ANYONE
THAT THIS APPLIES TO PLEASE
ENCOURAGE THEM.
SIMILARLY IN THE MENTORED K
SPACE, THERE IS A RESTORATION OF
ELIGIBILITY FOR CERTAIN K AWARDS
THAT WERE PREMATURELY ENDED,
AFTER JANUARY 1.
AND A COUPLE REVIEW-RELATED
THINGS, YOU'LL SEE LATER FROM
BRUCE, THE FRAMEWORK
IMPLEMENTATION HAS TAKEN EFFECT,
WENT INTO EFFECT FOR
APPLICATIONS ON OR AFTER JANUARY
25.
SO, THIS NOTICE REMINDS
APPLICATIONS, APPLICANTS, THAT
SRF WILL BE APPLIED TO ALL
RELEVANT APPLICATIONS FOR THE
AUGUST AND OCTOBER COUNCIL
MEETINGS.
AND IT EARLY EXPIRES NOFOs
THAT EXTENDS BEYOND THOSE DATES.
ICOS ARE IN THE PROCESS OF
DECIDING WHETHER THEY WILL BE
REISSUED BUT SOME ARE IN
PROGRESS.
AND LASTLY, WE'VE BEEN GETTING
SOME QUESTIONS ABOUT THE EARLY
EXPIRATION OF FELLOWSHIP
NOFOs.
REST ASSURED THAT THIS IS JUST
DUE TO THE NEED TO UPDATE THE
FORMS PACKAGE, WE UNDERSTAND
REISSUES ARE IN PROGRESS AND
WE'RE NOT ANTICIPATING ANY
DISRUPTIONS TO THE REGULAR
RECEIPT DATE IN AUGUST.
SO A LOT OF INFORMATION THERE,
AND I APOLOGIZE BUT FEEL FREE TO
READ MORE AND, AGAIN, ANSWER ANY
QUESTIONS BY E-MAIL OR OTHERWISE
IF THEY COME.
>> YEAH, THANK YOU, ANNA.
YEAH, THAT IS A LOT.
>> SORRY.
>> BUT, YOU KNOW, WE'LL HAVE
TIME FOR DISCUSSION AND THEN AS
ALL OF US HAVE SORT OF
REITERATED, THE DISCUSSION CAN
BE ONGOING, AS THESE ARE ALL
SORT OF TOUGH THINGS TO WRAP OUR
HEADS AROUND.
YOU'VE HEARD ABOUT THE
REORGANIZATION OF THE NIH AND
I'LL TOUCH ON SOME OF THE
REORGANIZATION PLANS ACROSS
INSTITUTES, BUT THERE ARE
STRUCTURES THAT CUT ACROSS ALL
INSTITUTES THAT HAVE BEEN
IDENTIFIED AS OPPORTUNITIES FOR
CENTRALIZATION OR
REORGANIZATION.
AND THE NUMBER ONE IS PEER
REVIEW.
SO, AS YOU GUYS ARE FAMILIAR
WITH IT, TRADITIONALLY
APPLICATIONS HAVE EITHER BEEN
ASSIGNED TO THE CENTER FOR
SCIENTIFIC REVIEW, OR TO NIC,
WHERE EACH INSTITUTE HAS HAD
THEIR OWN REVIEW TEAMS TO HELP
PROSECUTE UNIQUENESS OF TOPIC
AREA, THERE MAY BE A UNIQUE
FUNDING OPPORTUNITY THAT SORT OF
TUNED INTO THE MISSION OF THAT
INSTITUTE, SO WE AS INSTITUTES
HAVE ALWAYS HAD A REVIEW PROCESS
THAT'S A MINORITY OF ALL THE
APPLICATIONS THAT ARE COMING IN
BUT REALLY SERVING THE SPECIAL
FUNCTION AND MISSION OF THOSE
INSTITUTES.
AND THEN OF COURSE AFTER THAT,
WHETHER IT GOES TO CSR OR TO THE
INSTITUTE ITSELF AND IN OUR CASE
OUR PROGRAMS, Ks AND Ts,
MULTI-COMPONENT APPLICATIONS
NOTABLY THE P41 PROGRAM, WHICH
MANY OF YOU ARE FAMILIAR WITH,
AND HAS HAD ITS OWN SORT OF
UNIQUE REVIEW TYPES OF
APPROACHES BECAUSE WE'RE THE
ONLY INSTITUTE LEFT STANDING
THAT HAS A P41 PROGRAM THAT
DEDICATED EXCLUSIVELY TO CUTTING
EDGE TECHNOLOGY DEVELOPMENT,
MISSIONS DISSEMINATION AND SO
FORTH.
SO AFTER THAT, EITHER PATHWAY,
THE INSTITUTE WILL DEVELOP A PAY
PLAN, COUNCIL REVIEW FUNDING
DECISIONS, AND GRANTS AWARD.
THAT'S NO LONGER IN FORCE.
THE INSTITUTE PATHWAY HAS NOW
BEEN ELIMINATED, AND CSR IS IN
THE PROCESS OF BEING
REORGANIZED, INCLUDING
RECRUITING THE REVIEW OFFICERS
FROM EACH INSTITUTE TO COME INTO
THE CENTRAL CSR, AND SO WE'RE
FORTUNATE TO HAVE FOUR OF OUR
SROs MOVE INTO CSR TO HELP
REPRESENT THE INTERESTS OF OUR
COMMUNITIES, SO CSR ASSURES US
THAT THAT SPECIAL FUNCTION OF
PRESERVATION, PRESERVING THE
INTEGRITY OF WHAT OUR COMMUNITY
IS DOING WITHIN THE CSR AND SORT
OF MAKING IT FAIR FOR TECHNOLOGY
DEVELOPERS IN SORT OF THIS
LARGER STRUCTURE WILL BE ENSURED
SO WE'RE FOLLOWING THAT VERY,
VERY CLOSELY.
BUT BOTTOM LINE IS HERE THAT ALL
APPLICATIONS WILL GO THROUGH
CSR.
AND THIS IS A BIG
TRANSFORMATION.
IT'S A HEAVY ORGANIZATIONAL
LIFT.
TIME SCALE FOR THIS IS EXTREMELY
FAST.
I DON'T REMEMBER, WE DON'T HAVE
A DATE ON IT, BUT DO YOU GUYS
REMEMBER WHAT THE DATE IS?
>> I MEAN, IT WILL BE COMPLETE
FOR OCTOBER COUNCIL
APPLICATIONS, ALREADY IN
PROGRESS, ALL OF THE
ADMINISTRATIVE STAFF, SROs IN
CSR, SO IT'S HAPPENING NOW.
>> THESE ARE OUR BIGGEST, MOST
IMMEDIATE CHANGES IMPACTING THE
EXTRAMURAL COMMUNITY, ASIDE FROM
ALL OF THE OTHER THINGS, YEAH,
BUT THERE'S BEEN AN INCREASE IN
NUMBER OF APPLICATIONS, AND, YOU
KNOW, IT'S QUITE SUBSTANTIAL.
AND SO THIS IS INVOLVED AND
CONNECTED TO THE CENTRALIZATION
PEER REVIEW.
AND, YOU KNOW, CLOSE TO REVIEW
IS BUDGET.
SO LET'S GO OVER BUDGET UPDATES.
AND I HOPE NOT TO CONFUSE YOU.
THIS SITUATION FY 25 WE'RE
OPERATING UNDER A FULL-YEAR
CONTINUING RESOLUTION THROUGH
SEPTEMBER 30th, THAT'S AT FY
24 APPROACH RIGS LEVEL OF $441
MILLION.
FY 25 THERE'S AN IMPACT ON
SEVERAL NIH-WIDE PROGRAMS THAT
IN PARTICULAR NIBIB, OUR
COMMUNITY, IS FUNDED BY.
SO WE'VE HAD GREAT SUCCESS IN
WORKING WITH THE BRAIN
INITIATIVE, THAT'S TAKEN A HUGE
HIT.
I THINK AS MANY OF YOU KNOW FROM
$172 MILLION DOWN TO $91
MILLION.
THAT'S A DIRECT IMPACT ON OUR
COMMUNITY, WHICH IS PUTTING AN
INCREDIBLY IMPORTANT AND
IMPACTFUL ROLE IN DRIVING
FORWARD NEW NEUROSCIENCE AND
PARTICULARLY BRAIN IMAGING AND
BRAIN -- EVEN NEUROTHERAPEUTIC
APPLICATIONS.
ARPA-H IS UNAFFECTED BY THAT
CUT.
AND WE HAVE A NUMBER OF
INVESTIGATORS IN OUR COMMUNITY
IN GENERAL THAT ARE SUPPORTED
WIDELY BY ARPA-H.
SO THIS IS STILL QUITE VIABLE
PATHWAY, ALTHOUGH FY 26, YOU
KNOW, WE JUST DON'T KNOW WHAT
WILL BE COMING FOR EITHER OF
THOSE PROGRAMS.
SO THE R01 PAY LINE FOR PARENT
R01 ANNOUNCEMENTS BASED ON ALL
THE THINGS THAT HAVE BEEN
HAPPENING, WE'RE PRELIMINARILY
SETTING -- WELL, WE'RE SETTING
AND WE HOPE THIS STANDS BUT
THERE COULD BE OTHER CHANGES,
AND THAT'S THE CONFUSING PART.
SO WE'RE STILL LISTENING AND
WORKING WITH OUR BUDGET OFFICE
AND TO THE POLICIES THAT ARE
COMING OUT OF THE OFFICE OF
MANAGEMENT AND BUDGET.
SO THAT'S THE CAVEAT TO ALL OF
THIS.
SO OUR PAYLINE FOR R01 RIGHT NOW
IS 12%, 17 PER CENT FOR NEW
INVESTIGATORS, 29% FOR
EARLY-STAGE INVESTIGATORS.
AND THIS IS REALLY DESIGNED TO
SERVE THE NUMBER OF GRANTS THAT
WE'RE ABLE TO FUND, I'LL GET TO
THAT IN JUST A SECOND.
THIS IS THE BIG PICTURE.
THE FY 26 PRESIDENT'S BUDGET
REQUEST HAS I THINK MANY OF YOU
ARE FAMILIAR WITH, NIBIB
CONSOLIDATING INTO A NATIONAL
INSTITUTE OF GENERAL MEDICAL
SCIENCES, AND THE NIH TOTAL
BUDGET WOULD DECREASE 40% FROM
FY 25, ABOUT $27.5 BILLION,
NIBIB WOULD COMMENSURATELY BE
REDUCED DOWN TO $262 MILLION,
ROUGHLY OUR FY 2002 LEVELS,
INITIAL APPROPRIATION LEVELS.
SO, THAT'S THE PRESIDENT'S
BUDGET.
NOW, FY 25, WHAT ARE THE GOALS,
HOW DO WE COME UP WITH PAYLINE
TARGETS?
WE WANT TO SUSTAIN COMPETING R01
AWARDS IN THE 90 TO 95 BALL PARK
AS FOR SEVERAL YEARS, PROTECT
EARLY-STAGE INVESTIGATORS, AGAIN
ROUGHLY 15 TO 20 OF THESE R01
AWARDS FOR ESIs IN PREVIOUS
YEARS, THAT'S KIND OF KEY GOAL.
IN TERMS OF ADMINISTRATIVE
REDUCTIONS TO SOME COMPETING
AWARDS, THIS WOULD BE LESS
DRASTIC THAN LAST YEAR SO 10%
REDUCTION TO R01s TO ESIs,
AND ALL MODULAR BUDGETS LESS
THAN 250K, AS YOU KNOW, 20% TO
R01s TO NON-ESIs WITH
NON-MODULAR BUDGETS GREATEN THAN
250K.
SO THIS YEAR WE'RE HOPING TO
HAVE NO REDUCTION FOR
NON-COMPETING AWARDS,
CONTINUATION AWARDS WOULD BE
AWARDED AT FULL COMMITTED
LEVELS.
AGAIN TAKE A LOOK AT THE
FINANCIAL MANAGEMENT WEBSITE.
THIS IS A SNAPSHOT FROM THIS
MOMENT IN TIME AND IF YOU'RE
FOLLOWING PRONOUNCEMENTS FROM
THE OFFICE OF MANAGEMENT AND
BUDGET AND THEIR STRATEGY WE
COULD BE IMPACTED BY THOSE.
I MEAN, WE WILL BE IMPACTED BY
THOSE, IT JUST DEPENDS WHICH
ONES ARE REALLY ACTUALLY MOVING
FORWARD.
AND JUST A BRIEF SUMMARY IF
YOU'RE FOLLOWING THIS CLOSELY,
YOU MAY HAVE SEEN THE RELEASE
FROM THE WHITE HOUSE, I BELIEVE
ON FRIDAY LAST WEEK.
PROPOSED REORGANIZATION OF NIH
INSTITUTES AND CENTERS.
WE HAD A LOT OF CONVERSATIONS IN
PREVIOUS COUNCIL MEETINGS ABOUT
THE KATHY MCMORRIS ROGER
SUBCOMMITTEE PROPOSAL TO
REORGANIZE INTO 15 DIFFERENT
INSTITUTES AND CENTERS AND
MAINTAIN THE BUDGET AS IT WAS
EXACTLY BEFORE.
I DON'T KNOW IF WE HAD A CHANCE
TO ACCEPT THAT OFFER AT THAT
TIME.
IN RETROSPECT IT LOOKS PRETTY
GOOD.
SO HERE IS THE REORGANIZATION.
AND YOU SEE WHERE WE ARE, KIND
OF IN THE MIDDLE OF THIS TABLE
WHERE WE WOULD BE PART OF A
NATIONAL INSTITUTE OF GENERAL
MEDICAL SCIENCES WITH ABOUT A
$3.7 BILLION BUDGET.
WE DON'T KNOW EXACTLY HOW THIS
ORGANIZATIONAL STRUCTURE WOULD
LOOK.
LET ME GO BACK TO THE PREVIOUS
SLIDE AND LINGER ON THAT A BIT.
SO, OBVIOUSLY NIGMS, NHGRI,
NATIONAL LIBRARY OF MEDICINE,
US, AND NCATS WOULD BE COUPLED
TOGETHER.
AND THE OTHER INSTITUTES, YOU
CAN SEE THE NEW NOMENCLATURE
HERE, NCI, NIA, AND NIAID WOULD
EFFECTIVELY REMAIN THE SAME.
THESE ARE EITHER THE THREE
LARGEST, CERTAINLY TWO OF THE
THREE, I DON'T KNOW WHERE NIA
IS, PROBABLY UP THERE AS WELL,
YEAH, SO THEY WOULD BE
MAINTAINED AS INDEPENDENT
INSTITUTES.
GOING ALONG WITH THIS WOULD BE
THE ELIMINATION OF FOUR, NCCIH,
NIMHD, NINR, AND FOGARTY CENTER,
AND NIEHS WOULD MOVE OVER TO HHS
IN THE NEWLY CREATED AHA, I
FORGOT WHAT THAT STANDS FOR.
ADMINISTRATIVE --
>> NEW.
>> IT'S A NEW ADMINISTRATION.
SO TAKE A LOOK AT THAT BUDGET.
THERE ARE ALSO PRIORITIES IN.
THERE AS I NOTE, WE ALL NOTE,
THAT IT'S -- PRESIDENT'S BUDGETS
ARE TYPICALLY NOT ASKED, IF WE
LOOK AT PRIOR HISTORY, TIMES ARE
DIFFERENT NOW, SO WE JUST DON'T
KNOW HOW THIS IS GOING TO WORK
OUT.
LET ME RUN THROUGH RFAs AND
FUNDING OPPORTUNITIES.
WE WANT TO BRING TO YOUR
ATTENTION, SOME DUE DATES IN A
COUPLE DAYS LIKE THIS ONE,
YOU'RE FAMILIAR WITH THE AMAZING
POCTRN PROGRAM LED BY TIFFANY
TIFFANI LASH, AND WE HAVE
VISIBILITY WITHIN POCTRN FOR
EACH OF THE SITES TO SOLICIT
APPLICATIONS FOR AWARDS, AND GO
THROUGH POCTRN INTERNAL REVIEW
SO IT'S BEEN SORT OF A CLEVER
ORGANIZATIONAL AND
ADMINISTRATIVE OPPORTUNITY FOR
US TO ACCELERATE THE TURNAROUND
TIME FROM GREAT IDEA TO FUNDING,
AND STAY CONSISTENT WITH THE
MISSION OF THE U54 PROGRAM
ITSELF.
SO, WE'RE DOING THESE IN NEW
AREAS OF FOCUS, CHRONIC DISEASE,
LONG TIME FOCUS IN INFECTIOUS
DISEASE, BUT ALSO SOLICITING
THESE INTO PREVENTION, CANCER
DETECTION, HEART, LUNG, BLOOD
AND SLEEP DISORDERS, STIS
INVESTING LOTS OF EFFORT HERE,
AND EMERGING INFECTIOUS DISEASE
IN LOW-RESOURCE SETTINGS.
I ENCOURAGE EVERYONE TO TAKE A
LOOK AT THIS.
THIS IS -- IT'S A KIND OF --
IT'S A MECHANISM THAT WE HAVE
PIONEERED HERE AT NIBIB, I THINK
IT'S A GREAT INTEREST TO OTHER
INSTITUTES AND CENTERS.
AND IT'S REALLY THE FOUNDATIONAL
PROCESS THAT'S DRIVEN THE RADx
PROGRAM SO ELEMENTS OF THAT WILL
BE INTEGRATED INTO THIS SO THAT
DUE DATES ARE JUNE 6, GET IN
TOUCH WITH TIFFANI, BUT THESE
WILL BE COMING UP ON A REGULAR
BASIS.
SO, YOU KNOW, THIS WILL HAPPEN
AGAIN.
HOPEFULLY.
BUT, AGAIN, THAT'S SORT OF FY 26
BUDGETS.
WE'RE SO PROUD OF THIS PROGRAM
WITH ALL OF YOU HELPING PROMOTE
IT AND OUR COMMUNITIES.
I GET THE UNIQUE OPPORTUNITY TO
HAVE THE VIDEOS FROM OUR LEADERS
AND ENTRANTS AND THOUGH SHOW
THEM TO COLLEAGUES AT NIH AND
OTHER AGENCIES.
WHEN I REMIND THEM THESE ARE
UNDERGRADUATE STUDENTS, THEY ARE
ASTOUNDED.
IT'S THE MOST IMPACTFUL VIDEO I
CAN SHOW.
LET'S KEEP THIS UP.
IT'S HAVING AN IMPACT IN HELPING
PEOPLE UNDERSTAND THE ROLE OF
TECHNOLOGIES AND COMMITMENT OF
OUR EDUCATIONAL PROGRAMS AND
TALENT OF OUR YOUNG PEOPLE.
MY COLLEAGUES AND PEOPLE ACROSS
THE GOVERNMENT ARE ASTOUNDED.
WE'VE INCREASED TO $190,000,
REACH OUT TO DAVE AND TALK ABOUT
YOUR PROGRAMS AND THE CONNECTION
THAT YOU MAY HAVE WITH EACH OF
THESE SPECIAL AWARDS.
WE'VE BROKEN IT DOWN WITH
CO-FUNDING FROM MULTIPLE
INSTITUTES, INCLUDING NEW
TECHNOLOGIES FROM THE OFFICE OF
RESEARCH AND WOMEN'S HEALTH,
INSTITUTE OF AGING, AND FROM
VENTUREWELL, THE RISING STAR
PRIZE.
THIS IS ALL IN PROCESS.
I KNOW YOUR STUDENTS ARE LIKE
REALLY WORKING HARD TO GRADUATE
AND FINISH THEIR DESIGN PROJECTS
AND DO EVERYTHING
SIMULTANEOUSLY, BUT REALLY
ENCOURAGE THEM, WE'LL BE
ANNOUNCING WINNERS TRADITIONAL
AT THE CONFERENCE THIS YEARS IN
SAN DIEGO.
YOU MAY HAVE HEARD OF THIS
COMMON FUND INITIATIVE, WHICH IS
SPECIALLY FUNDED BY THE NIH
DIRECTOR'S RESERVE FUND, I
BELIEVE $50 MILLION SET ASIDE.
THIS IS QUITE A UNIQUE FUNDING
OPPORTUNITY.
HE PRESENTED THIS IN THE RECENT
COUNCIL OF COUNCILS MEETING, AND
SO I'LL HAVE A LINK IN ANOTHER
COUPLE SLIDES, MAYBE THE NEXT
SLIDE, TO THE VIDEO VIDEOCAST.
TAKE A LOOK.
I THINK THIS IS SOMETHING THAT
OUR COMMUNITY REALLY COULD MAKE
SOME MAJOR CONTRIBUTIONS IN
TERMS OF QUANTITATIVE TYPES OF
TECHNOLOGIES AND STUDIES THAT
MIGHT BRING CLARITY TO THE
INTENT OF THIS FUNDING
OPPORTUNITY.
AND THIS WAS INTRODUCED REALLY
ALMOST IMMEDIATELY UPON JAY'S
ARRIVAL SO CLEARLY SOMETHING
THAT JAY AND THE SECRETARY HAVE
THOUGHT ABOUT BEFORE HE EVEN
CAME ON BOARD, AND IT WILL BE A
RESULT OF THAT.
SPEAKING OF COUNCIL OF COUNCIL'S
JAY'S PRESENTATION AND APPROVAL
WE'VE BEEN WORKING DILIGENTLY
WITH OUR SUPER TALENTED NIBIB
PROGRAM LEADS AND MANY PROGRAM
OFFICERS ACROSS NIH, I BELIEVE
WE HAVE 19 INSTITUTES THAT ARE
ENGAGED IN THIS CONCEPT,
PRECISION MEDICINE WITH A.I.,
INTEGRATING IMAGING WITH
MULTI-MODAL DATA, MIKE CHAN IS
THE DIRECTOR OF NEI WERE THE
CO-CHAIRS, AND WE JUST RECENTLY
PRESENTED THIS AND YOU CAN SEE
THE QR CODES AND FOLLOW.
WE PRESENTED THIS AT COUNCIL OF
COUNCILS, A GOOD ONE TO WATCH.
DR. BHATTACHARYA HAS A
PRESENTATION ON THE OTHER
INITIATIVE IS ALSO A GOOD ONE TO
WATCH.
THE IDEA IS SOMETHING SO
INTUITIVE AND SO LOGICAL FOR OUR
COMMUNITY BUT IT'S REVOLUTIONARY
IN TERMS OF BRIDGING THE GAP
BETWEEN THE BASIC RESEARCH AND
CLINICAL CARE IS TO DEVELOP
MULTI-MODAL DATA INTEGRATION
APPROACHES, ADVANCE ALGORITHMS
THAT WOULD INTEGRATE MULTIPLE
MODALITIES, AND DRIVE THEM
FORWARD INTO CLINICAL
IMPLEMENTATION, IF YOU'VE SEEN A
RADIOLOGY REPORT THAT'S
DELIVERED TO A PHYSICIAN WITH
THE IMPRESSION THAT'S GOT A
SUMMARY OF TWO MINDS, YOU RELATE
THAT, JUXTAPOSE THAT WITH THE
MEGABITS OR GIGABITS OF
INFORMATION CONTENT IN THREE AND
FOUR D IMAGES REQUIRED IN
STUDIES, THERE'S SUCH AN
ENORMOUS GAP.
SO THERE'S GREAT POTENTIAL HERE
AND THAT'S A BIT OF THE SORT OF
SPIRITUAL CORE INTENT OF THE
PROGRAM.
THIS STILL HAS TO GO THROUGH
ANOTHER COUPLE OF HURDLES BUT IT
WAS VOTED ON BY COUNCIL OF
COUNCILS, NEARLY UNANIMOUS
APPROVAL, 12-2.
I CAN'T GET OVER THE 2 WHO VOTED
AGAINST IT.
YOU KNOW, IT'S JUST A VERY
BEAUTIFULLY CONSTRUCT AND
THOUGHTFUL PROGRAM, ONE OF THE
MOST IMPRESSIVE I'VE SEEN OF
COMMON FUND PROGRAMS, CERTAINLY
OUR COMMUNITY WILL MAKE A VERY
SIGNIFICANT CONTRIBUTION TO THE
OVERALL VISION AND MISSION OF
THIS.
IT HAS TO CLEAR THE NIH
DIRECTOR'S HURDLE ULTIMATELY TO
BE MOVED FORWARD AND I BELIEVE
THE HHS SECRETARY LEVEL, BUT I
THINK ALL SIGNS LOOK PRETTY GOOD
SO KEEP YOUR EYES ON THIS.
GO TO THE WEBSITE AND TRACK IT.
I'LL ZIP THROUGH UPCOMING
WORKSHOPS AN MEETING.
THE CONSORTIUM MEETING, GAIN OF
FUNCTION RESEARCH ANNA
MENTIONED, THIS TOUCHES ON A LOT
OF POTENTIAL ACTIVITIES IN THIS
FIELD, IN THIS COMMUNITY, SO
HOPEFULLY THAT TOPIC WILL BE
BROUGHT UP.
AND THIS IS SUCH AN IMPORTANT
AND GROWING AREA, PARTICULARLY
FOR QUANTITATIVE TYPES OF
APPROACHES AND MOVEMENTS OF
CONCEPTS TO REALLY SUPPORT THE
ENTIRE BIOCOMMUNITY, IN
NOVEMBER, HYBRID EVENT WITH LOTS
OF EXCITING PRESENTATIONS AND
PEOPLE COMING.
THIS NCI WORKSHOP ON
MICROSYSTEMS TECHNOLOGIES WAS
DELAYED, PART OF MY FEBRUARY OR
MY JANUARY COUNCIL SLIDE
PRESENTATION BUT JESSICA IS
LEADING OUR EFFORT HERE.
AND WE, OUR COMMUNITY, THE
NUMBER ONE BIOENGINEERING
APPLICATION FOCUS AREA IS IN
CANCER RESEARCH.
WE JUST ANALYZED THIS DATA FOR A
NASA MEETING JUST RECENTLY HELD
ON CANCER ENGINEERING AND CANCER
ENGINEERING IS GROWING
MICROSYSTEMS ARE FUNDAMENTAL,
17% OF OUR BUDGE NOTE CANCER
ENGINEERING TECHNOLOGIES, A VERY
IMPORTANT CONFERENCE AND I THINK
I'LL BE GIVING A TALK TO KICK
THIS OFF AND LOTS OF OUTSTANDING
INVESTIGATORS.
WILBUR IS PART OF THIS.
WILBUR, YOU MAY COMMENT ON THIS
A LITTLE LATER.
AND THEN IN CORONARY ARTERY
DISEASE THIS IS A JOINT WORKSHOP
WITH NHLBI, REALLY FOR SETTING
THE VISION FOR 2040, FUTURE,
GRAND CHALLENGES.
MARTIN HAS JUMPED INTO THIS
TOPIC.
IT'S VISION SETTING, AND
THINKING THROUGH HOW WE CAN MAKE
VERY SIGNIFICANT ADVANCES THAT
ARE ALSO WIDELY ACCESSIBLE, THAT
CAN IDENTIFY CLINICAL CORONARY
ARTERY DISEASE AND REDUCE
MORTALITY RATES WHICH AS WE NOTE
WITH DISCUSSION ON HEALTHY
OUTCOMES, TESTIMONY THAT IS
GIVEN IN CONGRESS ABOUT THIS
TOPIC, WHEN YOU DIG INTO CHANGES
IN CANCER AND CARDIOVASCULAR
DISEASE THEY HAVE BEEN ENORMOUS
AND FACILITATE AND DRIVEN IN
LARGE PART, I'M BIASED, BUT MANY
SPECTACULAR TECHNOLOGIC ADVANCES
IN EARLY DETECTION, EARLY
DIAGNOSIS, AND EARLY
INTERVENTION.
PROMISING TO AN EXCITING
WORKSHOP.
PROGRAM UPDATES, MATERNAL RADx
CHALLENGE WITH NICHD, THIS HAS
BEEN A $10 MILLION PRIZE
PROGRAM, SO SEAN LED THIS
OUTCOME REVIEW, SEAN MULVANEY,
ONE OF OUR INCREDIBLY TALENTED
PROGRAM OFFICERS, HELPING LEAD A
PORTION OF THIS PROGRAM, AROUND
THIS IS EXCITING, SOMETHING
INCREASINGLY WE NEED TO DO AND
COMMUNICATE TO STAKEHOLDERS, SO
FIRST OF ALL EIGHT OF THE TEN
TEAMS HAVE PLANNED OR INITIATED
CLINICAL TRIALS, IN THE SIX
MONTHS FOLLOWING THESE AWARDS,
QUITE MODEST, DRIVEN LEVERAGING
OPPORTUNITIES FOR EACH OF THE
COMPANIES, THREE TEAMS HAVE
SUBMITTED OR RECEIVED REGULATORY
APPROVALS, TWO TEAMS LAUNCHED
TECHNOLOGY, THREE INVOLVED IN
SCALING UP MANUFACTURING, SO FOR
QUITE MODEST INVESTMENTS BUT A
LOT OF OTHER SUPPORT, FROM
EXPERTS, GUIDANCE, INTERACTION,
COLLABORATIVE ACTION WITH FDA
THERE'S BEEN PROGRESS, ONE OF
THE KEY ADDED VALUES OF OUR
COMMUNITY AND THE NIBIB IN
GENERAL, $5 MILLION IN FOLLOW-ON
FUNDING.
SO INITIALLY WE SET UP A $10
MILLION AWARD STRUCTURE ACROSS
ALL OF THESE, AND ALREADY IN SIX
MONTHS 50% OF THAT HAS BEEN
REINVESTED WITH MORE JOBS BEING
CREATED.
THE TECHNOLOGIES THAT ARE THE
GRAND PRIZE WINNERS, SIX OF
THEM, ARE POINT OF CARE, SOME
POTENTIALLY HOME BASED, RAPID
TURNAROUND TIME, ALIGNED WITH
MOVEMENTS AND VISION OF OUR
FEET.
SEAN HAS BEEN LEADING THE VIRAL
LOAD INITIATIVE IN RADx AND
TODD WILL MENTION THIS.
WE HAVE THREE TEAMS THAT ARE
ACTIVE IN MILESTONE BASED
CONTRACTS.
THE CHALLENGE IS TO BE
QUANTITATIVE ABOUT VIRAL LOAD,
AND HAVE THE ABILITY TO
SENSITIVITY AND DETECTION LESS
THAN 200 COPIES PER ML.
YOU'D LIKE FINGER PRICK
SAMPLING, THAT'S A CHALLENGE.
PERHAPS TODD CAN ADDRESS THAT.
THESE HAVE HAD SIGNIFICANT
EXPERIENCE IN INNOVATION FUNNEL
WITH OTHER APPROACHES SO WE'RE
EXCITED ABOUT THE WAY THIS IS
GOING, IT'S A WONDERFUL
PARTNERSHIP WITH THE OFFICE OF
AIDS RESEARCH, ENCOURAGED IN
ADMINISTRATION, BENEATH THE
SURFACE OF IMPLEMENTATION
SCIENCE ARE ARE TECHNOLOGIES
THAT WILL GET US TOWARDS
IMPLEMENTATION.
A FEW UPDATES ON MIDRC, THE LEFT
COLUMN IS AUGUST OF 2020, WHEN
WE STARTED.
WE DIDN'T HAVE TRUSTWORTHY A.I.
AND MEDICAL IMAGING.
WE WERE FORCED BECAUSE OF
FUNDING AND URGENT NATIONAL NEED
TO FOCUS ON COVID AS A FIRST USE
CASE.
AND WHERE WE ARE IN 2025 WE HAVE
MIDRC BEING A LEADER IN
DEVELOPMENT OF THESE TOOLS WITH
ASTOUNDING NUMBER OF IMAGES AND
STUDIES RELEASED IN MANY TOOLS
UNDER DEVELOPMENT.
WE'VE EXPANDED MIDRC MODEL IN
CANCER, TRAUMATIC BRAIN INJURY,
OTHER CONDITIONS.
IT STARTED AGAIN IN AUGUST 2020
WITH X-RAY AND CT, NOW VIRTUALLY
EVERY CURRENT IMAGING MODALITY
THAT CAN BE INGESTED INTO THIS
DATABASE.
BACK AGAIN IN AUGUST OF 20 NO
COMMON INDEX OR DISCOVERY
PLATFORM.
MIDRC AND BIOMEDICAL DATA FABRIC
IMAGING HUB HAS PLAYED AN
INCREDIBLE TRANSFORMATIONAL ROLE
IN IMAGING OVER A MILLION
IMAGING STUDIES FROM ACR, FROM
CANCER IMAGING ARCHIVE, FROM
STANFORD.
THERE HAVE BEEN A NUMBER OF
SOURCES, GATHERED IN DATA LAKES
THAT WE'RE ENGAGED IN.
AND THERE'S BEEN JUST A LOT OF
DISCONNECTED EFFORTS EARLY ON TO
BUILD TRUST WORDY WORD -- TRUSY
IMAGING BUT COMING TOGETHER WITH
ACR, APM, SO WE'RE PROUD OF THIS
TRANSFORMATION.
IT'S INFORMING NATIONAL A.I. AND
DATA INFRASTRUCTURE INITIATIVES.
AND HAS JUST RECENTLY BEEN
EXTENDED FROM NATIONAL A.I.
RESEARCH RESOURCE, BIOMEDICAL
DATA FABRIC, AND DoD N TECH
SUPPORT FOR NEUROTRAUMA
TRAINING, AND SO JUST LOTS OF
ENORMOUS POTENTIAL HERE.
HERE IS A LITTLE SIMULATION OF
ONE OF THE PRODUCTS, ONE OF THE
TOOLS THAT'S BEEN DEVELOPED, RAD
GPT TO HELP PATIENTS INTERPRET
THEIR OWN RADIOLOGY REPORTS SO
YOU CAN SEE EVERY TIME YOU WOULD
GET A RADIOLOGY REPORT, THIS IS
ONE OF THE TOOLS THAT MIDRC
DEVELOPED AND WOULD ALLOW YOU TO
HYPERLINK IN A SORT OF
CONTINUOUSLY PROGRESSIVE
GENERATIVE APPROACH TO ADDRESS
PHRASES, CONCEPTS, THAT ARE
COMING UP THAT TYPICAL PATIENT
WOULD WANT TO GET FURTHER
INFORMATION ON.
THERE ARE A COUPLE RADGPTs OUT
THERE.
THIS IS ONE THAT'S A SIGNATURE
OF MIDRC, ANOTHER INCLUDES
SEGMENTATION DETECTION, AND
DIAGNOSIS TOOLS ALREADY BUILT
INTO GENERATIVE LANGUAGE TOOLS,
CONTINUING TO EVOLVE BUT SHOWING
A PRACTICAL PATIENT-READY AND
RELEVANT TOOL.
A AND NOTICED BY THE IMAGING
COMMUNITY.
BY COLLEAGUES AND LEADERS IN THE
FIELD OF IMAGING, SEVERAL
RECOMMENDATIONS FOR REALLY
MOVING QUANTITATIVE IMAGING
INFRASTRUCTURE ALONG WHICH HAS
TO BE FOUNDATIONAL FOR
REVOLUTIONIZING A.I. DRIVEN
PRECISION MEDICINE WITH CLEAR
RECOMMENDATIONS IN POINT TO
MIDRC, AS EXAMPLE OF A PROGRAM
THAT EMBODIES THE SPIRIT,
PHILOSOPHY, AND THE ACTION OF
THESE RECOMMENDATIONS.
SO LET ME CONCLUDE ALL OF THIS.
THE NIH DIRECTOR AGAIN I
ENCOURAGE YOU TO TAKE A LOOK AT
HIS PRESENTATION IN THE NINDS
COUNCIL.
HE DELINEATES SEVERAL
PRIORITIES.
I EXTRACTED THE ONES I THINK ARE
MOST IMPORTANT, OBVIOUSLY WE'RE
BIASED, TECHNOLOGY, DISCOVERY,
INNOVATION, THEY ARE WOVEN IN,
RELIABILITY, REPRODUCIBILITY,
TRANSPARENCY.
SO HIS TOP THREE ARE RELATED TO
THESE THINGS.
AND IN THE MIDDLE IS OUR KIND OF
BROAD DEPICTION OF WHAT WE DO AS
A COMMUNITY, FROM ENGINEERED
BIOLOGY AND SENSORS, POINT OF
CARE, IMAGING, THERAPEUTIC
SYSTEMS, DATA SCIENCE AND
MODELING.
YOU CAN'T REALLY GET TO ANY OF
HIS PRIORITIES WITHOUT PUSHING
THE ENVELOPE ON THE DEVELOPMENT
SO QUANTITATIVE TECHNOLOGIC
APPROACHES TO CHARACTERIZE
EVERYTHING FROM RELIABILITY AND
REPRODUCIBILITY, TO ADVANCING
NEW DISCOVERIES THROUGH
INNOVATIVE TECHNOLOGIES.
SO I THINK THIS IS THE
OPTIMISTIC AND POSITIVE
PERSPECTIVE THAT BRINGS OUR
COMMUNITY INTO POTENTIALLY
CENTRAL ROLE IN TRYING TO
REALIZE THESE PRIORITIES.
AND THEN FINALLY AS ANNA ALLUDED
TO WE HAVE THE CEREMONIAL PART
OF THE PRESENTATION.
TEJAL AND RAFAEL, THERE'S A
PHYSICS VIOLATION WHERE YOU'RE
COMING ON AND GOING OFF, OR
MAYBE IT'S A --
>> WE DON'T EXACTLY KNOW WHERE
HE IS YET.
>> THERE'S SOME UNCERTAINTY.
THE CERTAINTY THAT WE'RE HOPING
FOR IS THAT BOTH OF YOU WILL BE
ABLE TO JOIN US NEXT MEETING.
WE ALSO NOTE THAT ANNE PLANT WHO
I MET WHEN I JOINED 13 OR 14
YEARS AGO, ANNE MADE ENORMOUS
AND INSIGHTFUL CONTRIBUTIONS TO
ALL OF OUR PROGRAMS OVER THE
YEARS, HAS BEEN A WONDERFUL
COLLEAGUE AND COLLABORATOR.
ANNE HAS RETIRED FROM NIST, AND
SO IF YOU HAVEN'T REACHED OUT TO
ANNE, YOU SHOULD CONGRATULATE
HER ABOUT THAT.
WE MISS HER AND HOPEFULLY WE'LL
BE ABLE TO BRING ON -- SHE MIGHT
RECOMMEND SOME OF HER COLLEAGUES
TO SORT OF STEP INTO THAT ROLE.
BUT HOPEFULLY SHE'S ACTUALLY
ENJOYING HER RETIREMENT RIGHT
NOW.
AND WE THANK HER.
SO WITH THAT I'LL END THE
PRESENTATION AND WE CAN TAKE
SOME TIME FOR QUESTIONS.
>> THANKS, BRUCE.
WE'LL OPEN THE FLOOR FOR ANYONE
THAT HAS QUESTIONS.
COMMENTS.
>> THANK YOU, BRUCE, FOR GOING
THROUGH SO MANY IMPORTANT
DETAILS, NOT ALL OF THEM
PROBABLY WHAT YOU WANTED TO
REPORT, BUT WE THANK YOU FOR THE
TRANSPARENCY.
AND MY QUESTION IS ABOUT THE
FUTURE IF THE REORGANIZATION
PROCEEDS, WHAT KIND OF THINGS
CAN WE DO TO MAINTAIN THE SENSE
OF COMMUNITY THAT NIBIB HAS
BUILT?
WILL THERE BE DIVISIONS FOR OUR
SPECIALTIES IN THE NEW
STRUCTURE?
DO YOU HAVE ANY IDEA OR COMMENT
ON THAT?
>> YEAH, I GUESS TWO THOUGHTS.
ONE, I HAVE NO INDICATION THAT
THERE'S ANYTHING BEYOND A NICE
COLORFUL CHART.
I DON'T -- I HAVEN'T HEARD ANY
OPERATIONAL OR ORGANIZATIONAL
DETAILS TO SORT OF BACK THAT UP
ARE WE ON STILL?
OKAY.
>> WE'RE ON VIDEO, YEAH.
>> YEAH.
SO THAT'S ONE THOUGHT.
THE SECOND IS, YES, WE HAVE TO
KEEP DOING WHAT WE'RE DOING,
AND, YOU KNOW, REALLY PUSHING
HARD.
WE'VE ALL BEEN THROUGH
MULTI-DECADE-LONG BATTLE TO
CREATE THE UNIQUENESS AND
IDENTITY AND WE CAN'T STOP.
EVERY DAY WE LOOK FOR
OPPORTUNITIES TO TELL THE
STORIES OF OUR COLLEAGUES IN OUR
COMMUNITY FROM THE STUDENT
LEVEL, UNDERGRADUATES, TO THE
FACULTY LEVEL, THERE'S JUST SUCH
AN ASTOUNDING BODY OF WORK AND
IMPACT AND GROWTH.
SO, THAT PARTICULARLY I GUESS
HITS US HARD WHEN WE LOOK AT
THAT PROJECTED BUDGET ALLOCATION
FOR NIBIB, WHICH REMINDS ME
OF -- REMINDS US ALL OF THE
INITIAL BUDGET ALLOCATION TO
2002, AND YOU LOOK AT THE 40
BIOENGINEERING PROGRAMS AND KIND
OF THE SORT OF A LITTLE BIT OF
THE VIABLE RETENTION BETWEEN THE
RADIOLOGY AND IMAGING COMMUNITY
AND BIOENGINEERING COMMUNITY,
WHICH OVER THE YEARS WE'VE ALL
CONTRIBUTED TO AND WORKED SO
HARD TO RESOLVE AND FORM THAT
TRULY COLLABORATIVE AND
BEAUTIFUL STRUCTURE, WHERE
PEOPLE ARE JOINTLY APPOINTED
WORKING ON BIG PROJECTS AND SO
WE HAVE TO CONTINUE TO WORK
REGARDLESS OF THE REORG, IF
THERE IS OR IS NOT ONE, WE HAVE
TO
TO WORK HARD TO COMMUNICATE THAT
MENTAL.
WE'D LIKE TO SHARE THE STORIES,
YOUR STORIES, STORIES OF YOUR
COLLEAGUES, AS MUCH AS POSSIBLE,
AND IN EVERY OPPORTUNITY.
YOU NEVER KNOW WHEN THEY POP UP.
SO, WE WILL NOT TAKE OUR FOOT
OFF THE GAS.
YOU KNOW, ON THAT BIG PICTURE
VISION AND MISSION.
>> RAPHAEL?
>> RAPHAEL, YOU'RE ON MUTE, IF
YOU'RE TRYING TO SPEAK.
PERHAPS WE'LL COME BACK TO YOU
AND GO TO TEJON.
>> THANKS, BRUCE.
GREAT TO SEE YOUR PERSPECTIVE ON
EVERYTHING THAT'S HAPPENED, AND,
YOU KNOW, AS WAS JUST MENTIONED,
NIBIB HAS BEEN SO IMPORTANT TO
ME AND MOST OF US THAT ARE PART
OF COUNCIL RIGHT NOW.
SO I GUESS TO YOUR POINT ABOUT
HELPING YOU, IS THERE -- WE CAN
TELL OUR STORIES, PROVIDE YOU
WITH MATERIALS, I KNOW THROUGH
OUR PROFESSIONAL ORGANIZATIONS
WE'RE DOING OTHER WORK BUT ARE
THERE THINGS THAT WOULD BE
HELPFUL AND I PARTICULARLY AM
THINKING ABOUT THE STORIES ABOUT
HOW OUR WORK HAS DIRECTLY
TRANSLATED TO PRODUCTS AND
IMPACT ON PEOPLE AND ECONOMIC
GROWTH THAT MAY BE HELPFUL.
>> YEAH, THAT IS SO IMPORTANT,
AS WE KNOW.
YOU KNOW, ANOTHER CHARACTERISTIC
THAT WE ALL SHARE IS WE WANT
TO -- THIS IS INTENTIONAL, NOT
AN ACCIDENT.
THIS IS WHAT WE'RE DOING.
IT'S WHAT WE'RE TRAINING OUR
STUDENTS TO DO.
WE'RE NOT ONLY ADVANCING, YOU
KNOW, THE INNOVATION FROM THE
TECHNOLOGY POINT OF VIEW BUT
WE'RE ALL VERY INTERESTED AND
PASSIONATE ABOUT ADVANCING
INNOVATION AND PROCESS.
SO, YOU KNOW, WHEN WE HEAR SOME
OF THE MESSAGING ABOUT THE SORT
OF TRANSFORMATION OF THE NIH AND
GOVERNMENT, YOU KNOW, KIND OF
OUR FIRST RESPONSE IS, YEAH, BUT
THAT'S -- THIS IS LIKE WHAT WE
DO.
WE REALLY -- THIS IS BUILT INTO
OUR DNA.
SO, COORDINATING WITH US TO THE
EXTENT WE CAN, RECRUITING, YOU
KNOW, ANDY AND THE ACADEMY HAVE
BEEN INCREDIBLY SUPPORTIVE AND
COLLABORATIVE IN TRYING TO GET
THIS WORD OUT.
BUT I GUESS THE TIDAL WAVE OF
CHANGES YOU'RE HEARING, AND I
GAVE HIGH POINTS, YOU KNOW, IT'S
QUITE OVERWHELMING.
SO WE HAVE TO BUILD EQUIVALENT
MASS TO DO THE MASS AND ENERGY
BALANCE AND GET THAT SORT OF --
THOSE ACCOMPLISHMENTS AND THAT
WORD OUT AND TAKE ADVANTAGE OF
ANY OPPORTUNITY THAT YOU CAN TO
TRY TO HELP PEOPLE UNDERSTAND
THE SUCCESSES.
YOUR EDUCATORS, YOUR
COMMUNICATORS, WHAT WE
COMMUNICATE ONCE IT'S UNDERSTOD
YOU CAN SEE LIGHTS GO ON, BUT
THERE'S A BARRIER.
WE LIKE TO GO INTO PHYSICS AND
CHEMISTRY, MATH, AND THAT CAN
PUT PEOPLE TO SLEEP RIGHT AWAY,
BUT I THINK PEOPLE UNDERSTAND
THAT THOSE ARE THE FOUNDATIONAL
ELEMENTS OF ADVANCES IN
BIOMEDICAL RESEARCH, AND TO THE
EXTENT THAT I BRING THIS BACK TO
THE RELIABILITY,
REPRODUCIBILITY, IT'S JUST AN
OPINION WITHOUT QUANTITATIVE
ASSESSMENTS.
AND, YOU KNOW, WE TRY NOT TO
DEAL WITH OPINIONS.
WE TRY TO DEAL WITH REAL HARD
DATA, AND QUANTITATION.
SO I THINK IT'S KIND OF A UNIQUE
OPPORTUNITY FOR US TO STEP INTO
THAT, THAT SPACE.
AND THINK CREATIVELY.
>> CAN YOU HEAR ME NOW?
I APOLOGIZE IF WE'VE HAD REPAIRS
BEING DONE ON THE FIBEROPTIC
NETWORK HERE.
BUT I WANT TO TALK ABOUT
SUPPORTING AND WHAT BRUCE WAS
SAYING, WHAT'S BEEN
ACCOMPLISHED, YOU KNOW, SHOW THE
VALUE AND SUPPORTING MORE EFFORT
GOING FORWARD.
SO WHEN I THINK ABOUT IT, AND
TALK ABOUT IT, PUBLICLY, I
MENTION THAT IF YOU -- YOU CAN
FIND US IN MANY DIFFERENT PLACES
BUT GROWTH OF THE MERGE GDP,
FROM LIKE 1940s TO NOW, YOU
CAN PRETTY REASONABLY FIT THAT,
OBVIOUSLY NOT PERFECTLY, WITH
THE BILINEAR CURVE FIT, AND THEY
INTERSECT AROUND 1980, ALL THE
THINGS THAT HAPPENED IN 1980
THAT WOULD HAVE CAUSED A CHANGE
IN THE SLOPE, BUT ONE OF THEM
WAS THE BIDEN-DOLE ACT, A
HYPOTHESIS, A CANDIDATE.
IF YOU INTEGRATED THE AREA
BETWEEN THE TWO DIFFERENT
CURVES, THE PRE-1980 AND
POST-1980, WHAT YOU GET NOW, THE
LAST 40 YEARS, A LITTLE OVER
$100 TRILLION.
ACTUALLY $106 TRILLION TO BE
PRECISE.
SO IF THAT WAS IN FACT RELATED
TO TECHNOLOGY INGESTION FROM
PUBLIC SPENDING IN INVESTMENT
AND RESEARCH AND SO FORTH,
WHATEVER, THAT LED TO BUSINESS
DEVELOPMENT, IT'S TWO TRILLION
DOLLAR CONTRIBUTION TO THE
ECONOMY ON AVERAGE OVER THAT
PERIOD OF TIME PER YEAR.
I WONDER WHAT PEOPLE MORE EXPERT
THAN I TALK ABOUT THE SUBJECT IN
TERMS OF THE IMPACT OF NIH, WHAT
I FIND IN THE LITERATURE, REALLY
MORE PAROCHIAL ANALYSES OF HOW
MANY COMPANIES AND UNIVERSITIES
AND SO FORTH, BUT WHAT FIGURES
ARE YOU HEARING IN TERMS OF
IMPACT?
>> I THINK RAPHAEL IT'S A REALLY
GOOD AND INTERESTING MACRO
VERSUS MICROECONOMICS CONUNDRUM,
WHAT TYPES OF THINGS ARE MOST
EFFECTIVE HELPING PEOPLE
UNDERSTAND.
I THINK ON BOTH LEVELS, WE HAVE
TO DO A BETTER JOB SPEAKING AT
THE LEVEL OF LOCAL IMPACT, YOU
KNOW, IN REGIONS THAT HAVE
GROWN, OPPORTUNITIES FOR OUR
PEOPLE, FOR PEOPLE, NOT JUST OUR
PEOPLE WILL YOU TRANSFORMATIONAL
IMPACT IN HEALTH CARE IN VERY
PERSONAL WAYS, OUR NORMAL MODE
OF COMMUNICATION WHICH CAN BE
EXCITE SCHOLARLY AND MAY BE
ABSTRACT IN REQUIRING
CONNECTIONS TO BE MADE IN
DISCIPLINES WE'RE COMPETING
AGAINST NARRATIVES THAT ARE MORE
UNDERSTANDABLE AND VISCERAL TO
PEOPLE.
AND SO I THINK WE HAVE TO LEARN
AND HELP TEACH EACH OTHER WAYS
TO COMMUNICATE KIND OF ON THAT
SCALE AND IN THOSE TERMS.
AND WE CAN HAVE SOME -- MAYBE WE
SHOULD HAVE A SPECIAL
SUBCOMMITTEE.
WE CAN TALK MORE.
BUT, YOU KNOW, I FIND THAT, FOR
EXAMPLE, HAROLD VARMUS WROTE A
PIECE IN THE "NEW YORK TIMES,"
GOT NOBEL LAUREATES TO SIGN THIS
ABOUT DIRECTION AND BUDGET, BUT
I THINK THAT'S KIND OF, YOU
KNOW, FROM HELPING PEOPLE
UNDERSTAND THAT'S PART OF THE
ABSTRACTION AND KIND OF ELITE
REPRESENTATION.
WE NEED TO REPRESENT WHAT WE DO
MORE IN VERY PRACTICAL TERMS AND
UNDERSTANDABLE TERMS TO REALLY
IDENTIFY AREAS OF COMMON GROUND.
IN THE END, WE'RE QUITE A
PRACTICAL PROBLEM-SOLVING
COMMUNITY.
IT IS A CHALLENGE AND WE'RE KIND
OF AT THAT SORT OF CROSS-ROADS
OF THE CHALLENGE TO COMMUNICATE
IN THOSE TERMS, AND WE'LL SEE
HOW THAT PLAYS OUT IN THE BUDGET
HEARINGS AND SO FORTH.
BUT YOU GUYS BRING UP BIG AND
CHALLENGING TOPICS HERE.
>> KEEP YOU ON YOUR TOES.
>> YEAH.
>> ONE LITTLE THING, B BAYH AND
DOLE WROTE AN EDITORIAL
CONGRATULATING THEMSELVES FOR
THIS BILL, WHICH WAS VERY
EFFECTIVE IN DOING EXACTLY WHAT
THEY WANTED TO DO, WAS TO
INCREASE INNOVATION AND GROW THE
ECONOMY.
>> YEAH.
>> A GOOD PLACE TO START.
>> YES.
>> JOYCE?
>> THANK YOU FOR THE
TRANSPARENCY.
I WANT TO FOLLOW ON SOMETHING
TAJ EL BROUGHT UP, DIFFERENT
WAYS TO ENGAGE WITH THE PUBLIC,
I'M THINKING ABOUT WITH
CONGRESS.
I'M CURIOUS THAT THE -- I THINK
APRIL 30th, THE CONGRESSIONAL
HEARING THAT SUSAN COLLINS FROM
MAINE RAN, YOU KNOW, WITH PATTY
MURRAY IN WASHINGTON AND OTHERS,
ANOTHER SENATOR FROM ALABAMA.
CURIOUS HOW EFFECTIVE THAT WAS
OR WHAT YOU KNOW, AND ALSO I
GUESS THE QUESTION IS BRINGING
IN PATIENT ADVOCATES BUT I'M
WONDERING WHAT WAS THE OUTCOME
IF YOU CAN SHARE?
I REALIZE THE NIH, YOU KNOW,
ISN'T ABLE TO GO THERE DIRECTLY
BUT CURIOUS HOW IMPACTFUL THAT
CONGRESSIONAL HEARING WAS.
>> YEAH, I MEAN, WELL, IN THE
END I THINK BY THE SORT OF WHEN
IT COMES DOWN TO VOTES ON THE
PRESIDENT'S BUDGET, WHERE THE
NIH BUDGET STANDS, THAT'S SORT
OF THE END MEASURE, OUTCOME
MEASURE OF IMPACT.
SO, PATTY, SENATOR MURRAY, HAS
MADE SOME VERY STRONG STATEMENTS
WITH RESPECT TO THAT.
AND THE SECRETARY HAS MADE SOME
VERY STRONG STATEMENTS.
FROM A PERSONAL OBSERVATION PER
SPECK
PERSPECTIVE, I DIDN'T SEE LIVE
MOMENTS BUT READ THE FULL
TRANSCRIPT.
I WAS THINKING, SENATOR MURRAY,
SHE MAY HAVE PERHAPS BENEFITED
FROM SOME MORE FACT-BASED
BRIEFING FROM OUR COMMUNITY TO
THE EXTENT THAT OUR PROFESSIONAL
SOCIETIES OR, YOU KNOW, YOU GUYS
YOURSELVES HAVE WAYS TO PROVIDE
THAT.
HAVING RELIABLE AND ACCURATE
INFORMATION CONTENT, YOU KNOW,
THOSE CAN HELP CHANGE SOME SOUND
BITES AND NARRATIVES THAT COULD
PROPAGATE INTO DECISIONAL
ASPECTS OF THE SUBCOMMITTEE
VOTES.
SO I THINK KIND OF EVERYTHING
THAT YOU CAN IMAGINE, AND,
AGAIN, JOYCE DON'T HESITATE TO
REACH OUT, ALL OF YOU, TO
BRAINSTORM ABOUT THINGS.
BUT IT IS SORT OF A STRUGGLE TO
REALLY REPRESENT THE VERY
BEAUTIFUL AND AMAZING THINGS OR
COMMUNITY HAS DONE IN WAYS THAT
ARE SUFFICIENTLY INTERESTING AND
QUICK, AND APPEALING.
SO THIS IS SOMETHING WE ALL NEED
TO WORK ON.
>> I'M TRYING TO LET SOMETHING
ELSE GO, I ALREADY ASKED A
QUESTION.
BUT I GUESS I'LL GO AHEAD.
YOU KNOW, ONE OF THE THINGS, I
THINK THIS IS REALLY SOMETHING I
GRAPPLE WITH, GIVEN MY ROLE AS A
DEAN, IS STILL TRYING TO IMPART
OPTIMISM IN TERMS OF OUR EARLY
CAREER FACULTY AS WELL AS OUR
TRAINEES IN TERMS OF PURSUING
BIOENGINEERING RESEARCH,
BIOMEDICAL RESEARCH MORE
BROADLY.
I WANTED TO ASK YOU DO YOU HAVE
ANY SORT OF WORDS THAT I CAN
SHARE IN TERMS OF, YOU KNOW, DO
THEY KEEP APPLYING, DO THEY KEEP
SORT OF PUSHING AHEAD?
BECAUSE I THINK THE MESSAGES
THAT ARE CERTAINLY THAT THEY ARE
HEARING THAT MAYBE THEY SHOULD
WAIT IT OUT, MAYBE THEY SHOULD
SEE WHAT'S -- SEE WHETHER THE
FIELD OF BIOENGINEERING STILL IS
INTACT AS WE GO FORWARD.
SO CURIOUS, FOR ME THAT'S THE
BIGGEST WORRY I HAVE, SORT OF
THE NEXT GENERATION.
>> YEAH, THAT IS RIGHT AT THE
CORE OF THE MATTER.
I KNOW ALL OF YOU GUYS ARE
VIEWING WITH GRADUATE PROGRAM
ENROLLMENTS, OFFERS OF NUMBERS
OF SLOTS.
THE UNCERTAINTY THAT ALL OF THE
PROVOSTS IN THE COUNTRY HAVE.
I MEAN, WE JUST THROW THE ONE,
YOU KNOW, POLICY NOTICE ABOUT
THE 15% INDIRECT COST RATE ON A
SLIDE, AND THAT, THE
IMPLICATIONS OF THAT, YOU KNOW,
IF IT REALLY COMES TO PASS ARE
SO CONFOUNDING AND IT'S JUST
SUCH A CONUNDRUM FOR PLANNING.
STRUCTURAL DEFICITS WILL EMERGE,
UNIVERSITIES AROUND THE COUNTRY
IF THEY HAVEN'T ALREADY IN
CERTAIN PLACES, AND SOME ARE
TARGETED MORE THAN OTHERS, OF
COURSE, SO I GUESS MY OPTIMISM
IN THE MIDDLE OF ALL OF THE SORT
OF CHAOS IS THAT -- I THINK AS
ALL OF YOU HAVE SEEN AND
EXPERIENCED THROUGHOUT YOUR
CAREERS, TECHNOLOGY PROGRESSION
IS RELENTLESS.
WHETHER OR NOT IT'S ACTUALLY
FUNDED BY THE NIH.
AND WE SPENT AN ENORMOUS AMOUNT
OF TIME UNFUNDED.
AND WE'VE, AS A COMMUNITY, HAVE
MADE OURSELVES VALUABLE, AND IN
FACT INVALUABLE, IRREPLACEABLE.
BUT THAT ARC HAS BEEN QUITE
MODEST WITH THE INTEGRATION OF
MULTIPLE SOURCES AND MULTIPLE
STAKE HOLDERRERS FROM A VARIETY
OF DIRECTION.
I HAD NIH SUPPORT LEVERAGE,
DoD SUPPORT LEVERAGE, NSF, YOU
KNOW, SO WE WERE RELENTLESS AND
INVENTIVE AND HAVE TO MAINTAIN
THAT CHARACTERISTIC.
OUR YOUNG PEOPLE, OUR TRAINEES,
ARE DRAWN TO OUR FIELD BECAUSE
OF THOSE KIND OF INTRINSIC
CHARACTERISTICS AND MISSION AND
DRIVE, SO WE NEED TO SUPPORT AND
ENCOURAGE THAT.
AND BE REALISTIC, OF COURSE, BUT
IT'S -- I THINK SOME OF THESE
THINGS OVER TIME WILL STABILIZE.
I DON'T KNOW WHICH ONES.
BUT I FEEL LIKE OUR SECTOR
ALREADY ONE OF THOSE BECAUSE
REALLY NOTHING CAN HAPPEN
WITHOUT IT.
AND I MEAN I KNOW THAT'S A VERY
BIASED VIEW BUT IF YOU JUST LOOK
ACROSS ALL THE APPLICATION
ORIENTED INSTITUTES, EVERY
DISCOVERY, EVERY ADVANCE, REALLY
IS DRIVEN BY VERY BEAUTIFUL
ENABLING FOUNDATIONAL
APPROACHES.
WE CAN -- BETWEEN ALL OF US ON
THE CALL WE CAN GO BACK, CAN YOU
PLAY A GAME, PICK ONE DISCOVERY
AND WE COULD POINT TO HALF A
DOZEN KEY TECHNOLOGIC ADVANCES
THAT FACILITATED IT.
AND TELLING THOSE STORIES,
REMINDING OUR COMMUNITY OF THAT
ESSENTIAL FEATURE OF WHAT THEY
DO, I THINK IS THE OPTIMISTIC
COMPONENT.
I FEEL LIKE, YOU KNOW, AGAIN
THIS WILL EMERGE OVER TIME,
REPEATEDLY, AS A THEME.
AND I THINK THAT'S PART OF WHAT
WE HAVE TO CONVEY.
BUT I DO FEEL VERY SIGNIFICANTLY
THE PAIN OF LIMITING THE
GRADUATE ADMISSION, RESCINDING
GRADUATE OFFERS, AND WE HAVE TO
KIND OF THINK URGENTLY ABOUT HOW
TO ADDRESS THOSE CHALLENGES.
>> WILBUR?
>> BRUCE, THANK YOU AGAIN, FOR
YOUR PRESENTATION AND YOUR
CANDOR.
REGARDING THE 22% REDUCTION IN
YOUR STAFF AT THE NIBIB, WHAT'S
BEEN THE BIGGEST IMPACT?
I FRANKLY WANT TO HELP YOU AND
DISSEMINATE THROUGHOUT OUR
COMMUNITY, YOU KNOW, WHAT YOU
GUYS ARE UP AGAINST AND HOW
YOU'VE BEEN BASICALLY HAVING TO
DO MORE WITH LESS, BUT WHAT'S
BEEN THE BIGGEST IMPACT, FROM
YOUR MIND?
>> YEAH, I THINK YOU KNOW THIS
HAVING UNIQUELY BEEN INVOLVED SO
MUCH, IN THE COMMUNICATION OF
WHAT YOU DO, WHAT YOUR CENTER
HAS ACCOMPLISHED THROUGH THE
RADx PROGRAM AND BEYOND.
YOU'VE WORKED SO SEAMLESSLY WITH
OUR INCREDIBLY TALENTED OFFICE
OF SCIENCE AND POLICY AND
COMMUNICATION.
WE'VE BEEN TABLED TO HELP PEOPLE
UNDERSTAND THROUGH EXPERTISE THE
VERY SIGNIFICANT CONTRIBUTIONS
THAT ARE COMPLETELY UNEXPECTED,
NO ONE IN THE SORT OF
CONVENTIONAL WORLD EVER IMAGINED
THAT THIS COULD OCCUR.
AND SO WITH THE RISK THAT ENTIRE
TEAM AND NOW POTENTIALLY
RESTORATION, ALTHOUGH IT'S STILL
IN PROGRESS, WE DON'T REALLY
KNOW HOW THAT'S GOING TO PLAY
OUT, BUT SEARCH THE NEAR TERM
IT'S REALLY SHUT DO YOU THINK
OUR STREAM OF COMMUNICATIONS
THAT HAVE BEEN I THINK STRONGLY
APPRECIATED BY OUR COMMUNITY.
AND BY MORE THAN JUST OUR
PEOPLE.
YOU KNOW, IT'S REALLY MANAGED TO
WORK ITS WAY INTO POPULAR PRESS
AND INTO INFORMING THE ENTIRE
AMERICAN PUBLIC.
SO THAT'S A BIG IMPACT.
WE'RE HOPEFUL THEY WILL COME
BACK NOT ONLY, YOU KNOW, PERHAPS
TO A REORGANIZED COMMUNICATIONS
TEAM, ALL ACROSS THE NIH, BUT
COMMUNICATION THAT OUR COMMUNITY
IS DOING NEEDS TO BE REPRESENTED
WITHIN NIBIB, SO WE'RE HOPEFUL
THAT THERE WILL BE SOME SORT OF
HUB AND SPOKE MODEL WHERE WE'LL
STILL HAVE THE EXPERTISE
CONSERVED TO SOME EXTENT BUT
THAT'S NOT SETTLED YET.
AND THEN, YOU KNOW, THERE'S JUST
BEEN A VERY BIG ONGOING
DISCUSSION ABOUT ACQUISITIONS,
PROCUREMENT, CONTRACTING
OFFICERS ACROSS THE NIH.
WHICH YOU MAY HAVE READ ABOUT,
BUT INITIALLY WITH THE DISMISSAL
OF ALL THE QUALIFIED CONTRACTING
OFFICERS, WHICH BILLIONS OF
DOLLARS IN CONTRACTS NO ONE CAN
ACTUALLY EXECUTE THEM, SO SOME
COMING BACK, SOME PLAY NOT --
MAY NOT BE.
IT'S NOT SETTLED.
IT'S A TOPIC PROMOTED RIGHT TO
THE FRONT, MATT MEMOLI, ERIC
SHANABEL AND JAY HAVE BEEN
WORKING ON IT BUT I HOPE BY
SEPTEMBER IT WILL HAVE WORKED
OUT BUT IT'S URGENT BECAUSE IT'S
REQUIRED FOR REGULAR PURCHASING,
FROM INTRAMURAL LABS, ESSENTIAL
FUNCTIONALITY OF EXTRAMURAL
PROGRAMS, SO THIS IS STILL AN
ONGOING TOPIC.
>> LET MY ADD MY THANKS TO YOU
AND THE NIBIB TEAM FOR
EVERYTHING YOU'RE CONTINUING TO
DO.
ONE THING AS YOU WERE TALKING
ABOUT IMPACT, THERE IS ONE AREA
WHOSE IMPACT NOBODY BEGINS TO
DEBATE, THAT'S A.I.
AND I'M WONDERING, A, WHERE A.I.
MIGHT LAND AT THE NIH, AND, B,
IF IT CAN LAND AS I WOULD ARGUE
IT SHOULD IN SOME PRETTY
SIGNIFICANT FOCUSED WAYS AT
NIBIB.
I THINK OF THE INSTITUTES THERE
ARE LOTS OF USERS OF A.I. BUT
OUR COMMUNITY IS PROBABLY MOST
RICH IN THE DEVELOPERS OF A.I.
METHODS.
AND YOU TALKED ABOUT THE PRIME
TO A.I. INITIATIVE, FANTASTIC IN
LINE WITH MANY PRIORITIES I'VE
SEEN OF THE CURRENT
ADMINISTRATION, FOR EXAMPLE, IS
THERE ANY WAY MAYBE IN ADDITION
TO TELLING OUR DIVERSE STORIES
OF IMPACT THAT WE CAN MAYBE
FOCUS A LITTLE BIT AND TURN INTO
KIND OF THE A.I. INSTITUTE?
>> YEAH, AND I THINK THIS IS
PART OF OUR MISSION AND
RESPONSIBILITY TO NOT ONLY KIND
OF COMMUNICATE THE EXTENSIVE
INVOLVEMENT WE HAVE IN A.I., I
MEAN EVEN FROM PROGRAMMATIC
POINT OF VIEW CO-LEADING PRIME
TO A.I., CO-LEADING THE OTHER
MAJOR BRIDGE TO A.I. INITIATIVE,
WHICH WE MAY PORE MAY -- MAY OR
MAY NOT BE GOING FORWARD IN
COMMON FUND, PROPOSED SEVERAL
OTHER INITIATIVES, SUBJECT
MATTER EXPERTS ARE STRONG
LEADERS IN A.I. AND THE DOUBLE
EDGED WORLD.
AS AN INVERSE PROBLEM
AFICIONADO, THIS DRIVES ME
CRAZY.
NO ONE EVER SOLVED AN INVERSE
PROBLEM IN THAT COMMUNITY, AND
SO THEY HAVE TO INVENT NEW
TERMINOLOGY, BUT WE KNOW THEY
WILL POST INVEST PROBLEMS, YOU
KNOW, PI SQUARED MINIMI NOW
KNOWN AS HALLUCINATIONS.
TO HELP COLLEAGUES UNDERSTAND
LIMITATIONS OF A.I. AND NOT JUST
HAVE PEOPLE WHO ARE WELL VERSED
AND SCHOOLED IN POLICY AND
POLITICIAN TO RUN THE DEBATE, SO
WE HAVE THE CAPACITY IN OUR
COMMUNITY TO HELP GUIDE POLICY
AND HIGHER LEVEL DECISIONS ABOUT
A.I., SO JUMP IN THERE AND BE
REPRESENTED.
AND WE -- I CAN'T SORT OF TALK
ABOUT ANY MORE DETAILS THAN
THAT, OTHER THAN WE ARE VERY
MUCH INVOLVED IN THAT, AND I'M
PLEASED TO SAY THAT, YOU KNOW,
ETERNALLY PEOPLE LOOK TO US AS
AT LEAST THE MECHANICS WHO
UNDERSTAND HOW THE CAR WORKS.
BUT, YOU KNOW, I READILY REMIND
PEOPLE, EVERYBODY DOESN'T HAVE
TO KNOW LINEAR A LITTLE ALGEBRA
BUT AVOIDING HALLUCINATIONS IS
SOMETHING THE IMAGING COMMUNITY
HAS BEEN WORKING ON FOR QUITE
SOME TIME, UNDERSTANDING POWER
OF THE LIMITATIONS AS IT BECOMES
INCREDIBLY ACCESSIBLE AND PEOPLE
ARE HOPEFUL FOR ADOPTION, WE CAN
MAKE A REALLY STRONG
CONTRIBUTION TO THE TRUTH,
TRUTHFUL APPLICATIONS, BUT ALL
OF YOU GUYS HAVE TO PARALLELIZE
THAT MESSAGE IN EVERY ONE OF
YOUR DOMAINS AND PEOPLE NEED TO
THINK FIRST, IT EXTENDS OF
COURSE TO YOUR STUDENTS, GIVING
THEM PROPER SKILLS AND
BACKGROUND AND TRAINING.
A.I. FIELD HAS MOVED SO FAST
THAT JOBS IN A.I., TODAY, ARE
VERY DIFFERENT.
YOU MAY GET A JOB IN A.I. FOR
YOUR SKILL IN DEVELOPING INITIAL
GUESSES, AS OPPOSED TO, YOU
KNOW, ACTUALLY WRITING NEW CODE.
SO, YEAH.
THAT'S A BIG, BIG CHALLENGE.
>> A QUICK FOLLOW-UP IS, YOU
KNOW, TIME WAS THE ROLE OF
GOVERNMENT IN A.I., LARGELY SEEN
AS A REGULATORY ROLE.
BUT SORT OF IN OPPOSITION TO
LARGE COMPANIES WHO WERE DOING
INNOVATION, I JUST THINK IT
WOULD BE AN INTERESTING REFRAME
FOR GOVERNMENT TO BE PART OF THE
INNOVATION.
AND FOR NIBIB TO BE AT THE
CENTER OF THAT SORT OF
INNOVATIVE THREAD, PERHAPS
WORKING WITH COMPANIES.
BECAUSE I THINK AGAIN THERE ARE
A LOT OF -- YOU TALKED ABOUT US
AS THE MECHANICS WHO UNDERSTAND.
WE DON'T JUST UNDERSTAND, WE
BUILD THE A.I.s NOW.
WE BUILD THEM WITH PROTECTION
AGAINST HALLUCINATION.
WE BUILD THEM IN NEW WAYS, TO DO
NEW TASKS, NOT COPY WHAT HUMANS
HAVE DONE.
I DO THINK, I DON'T KNOW,
THERE'S A FUTURE I COULD
ENVISION ANYWAY WHERE NIBIB IS
ACTUALLY BEING THE GOVERNMENT
ARM OF A.I. INNOVATION, JUST
FOOD FOR THOUGHT.
>> I THINK SPIRITUALLY WE CAN
MANAGE TO GET PEOPLE ON BOARD
WITH THAT.
FROM A SIZE OR MASS POINT OF
VIEW, YOU KNOW, WE'RE STRUGGLING
THERE.
BUT PEOPLE WILL LOOK TO AND TURN
TO US, PRIMED A.I. APPROACHES,
ADVANCES, SO THE MIDRC
FOUNDATION HAS GIVEN PEOPLE A
LOT OF CONFIDENCE IN OUR SORT OF
COLLECTIVE VISION FOR WHAT
IMPACT WE AS A COMMUNITY CAN
HAVE ON A.I.
BUT, YOU KNOW, I THINK WE'RE,
AGAIN, TO EXPAND OUR EFFECTIVE
MASS REQUIRES ALL OF YOU GUYS,
KIND OF CONVEYING THAT MESSAGE.
WE ARE, WE PART OF THE NATIONAL
A.I. RESEARCH RESOURCE, PART OF
THE BIOMEDICAL DATA FABRIC.
THIS, YOU KNOW, MIDRC NOW HAS
GOTTEN FUNDING FROM M TECH,
DoD'S M TECH PROGRAM FOR
TRAUMATIC BRAIN INJURY.
SO THESE ARE SINE QUA NONES OF
DATABASES, ALGORITHM
DEVELOPMENT, FDA COLLABORATION,
AND ALGORITHM CLEARANCE AND
PARTNERSHIP WITH FDA AND
SOFTWARE MEDICAL DEVICE, YOU
KNOW, IS SOMETHING THAT PEOPLE
KIND OF TALK ABOUT BUT OUR
COMMUNITY ACTUALLY DIGS DOWN
DEEP INTO.
AND THERE'S A LOT OF
INTERCHANGEABLE EXPERTISE
BETWEEN THE FDA FOLKS WHO ARE
PROSECUTING AND DOING THAT AND
NICK MIGHT HAVE THOUGHTS ON
THIS, LET'S GET THIS STUFF DONE.
AND THOSE ARE GREAT
OPPORTUNITIES.
>> GREAT OPPORTUNITIES FOR SURE,
LESS ABOUT BUILDING FUNDAMENTAL
BENCHMARKS BUT INTEGRATING INTO
CLINICAL CONTEXT, USING THEM IN
EFFECTIVE WAY, HOW DO YOU AVOID
HALLUCINATIONS OR AVOID NEGATIVE
CONSEQUENCES FROM THE A.I., HOW
DO YOU MAKE IT WORK IN THE
WORKFLOW AND CLINICAL SETTING,
WHAT ARE THE RIGHT APPLICATION
AREAS, HOW DO YOU INTEGRATE WITH
THE READERS AND HUMANS, AND THEN
OF COURSE FROM OUR SIDE HOW DO
YOU -- WHAT TYPES OF TESTING,
EVALUATION, METHODOLOGY ARE
NEEDED.
AGAIN TALKING ABOUT THINGS LIKE,
BRUCE, INVERSE PROBLEMS,
RECONSTRUCTIONS, YOU'RE TALKING
ABOUT, YOU KNOW, RADIOLOGY
REPORT GENERATION WHICH IS A BIG
EAR NOW THAT PEOPLE ARE MOVING
INTO, ALL THESE THINGS THAT ARE
REALLY IMPORTANT AND
UNDERSTANDING THOSE FROM A
RESEARCH PERSPECTIVE AND
ADVANCING THAT I THINK IS A
GREAT WAY TO PARTNERSHIP WITH
NIBIB AND OTHERS TO MAKE THAT
REALLY MOVE FORWARD BECAUSE
THAT'S GOING TO BE REALLY A KEY
AREA TO MAKES THIS FUNCTION
WORKABLE AND EFFECTIVE IN THE
CLINICAL SETTING.
>> YEAH, AND WHERE THERE'S NOT A
MARKET YET, AND THERE'S GOING TO
BE A LOT OF MARKET DISRUPTION,
AS MULTI-MODALITY APPROACHES
COME OUT LIKE WHO IS GOING TO BE
MARKETING AND WHAT'S THE PAY
STRUCTURE FOR A MULTI-MODALITY
IMAGE PLUS GENOMIC PLUS CLINICAL
HISTORY INTEGRATION INTO THE
DECISION MAKING?
ARE THOSE GOING TO BE THINGS
THAT SMALL COMPANIES ARE GOING
TO BE PUSHING OUT TO INDIVIDUAL
PRACTITIONERS?
SO THEY CAN OPTIMIZE HOW THEY
TREAT THEIR OWN PATIENTS IN
SMALL GROUPS OR BE ONLY LICENSED
AND USED BY SORT OF LARGE HEALTH
CARE DELIVERY SYSTEMS, SO A LOT
OF THIS IS IS GOING TO COME DOWN
TO HOW THE FDA VIEWS CLAIMS AND,
YOU KNOW, THIS IS A VERY DYNAMIC
SPACE BUT I THINK WE -- A LOT OF
OUR YOUNG ENTREPRENEURS ARE
SUPER INTERESTED IN IF YOU TALK
TO ANY ENTREPRENEUR CLASS OR
INNOVATOR CLASS, EVERYBODY'S GOT
A.I. ON THEIR HORIZON, AS ONE OF
THE TOOLS THEY ARE GOING TO
RELEASE, AND I THINK MAYBE
MATHEMATICALLY IMPOSSIBLE FOR
START-UPS TO GET SUFFICIENT
AMOUNT OF DATA NECESSARY FOR
RELIABLE DECISION MAKING.
SO IT GETS ME BACK TO THE
COMBINATION, PHYSICS AND MACHINE
LEARNING MODELS, WHERE YOU HAVE
EXPLAINABILITY,
INTERPRETABILITY, AND THERE'S A
FEW REALLY BEAUTIFUL DE NOVO
CLEARANCE EXAMPLES, SOFTWARES,
MEDICAL DEVICE, FROM FDA IN 2024
THAT INTEGRATE THOSE.
AND THEN A LOT OF THOUGHT GOING
INTO THE CLAIMS, SO HIGH
SENSITIVITY, BUT NOT
SPECIFICITY.
SO KIND OF SCREENING TYPES OF
APPROACHES FOR CLINICAL DECISION
MAKING, SO THIS IS DEFINITELY
SOMETHING WE HAVE TO -- OUR
COMMUNITY HAS TO GET INTO THIS
DISCUSSION AT EVERY LEVEL.
>> OKAY.
IF THERE ARE NO OTHER QUESTIONS,
THANK YOU, BRUCE, FOR YOUR TALK
AND COMMENTS.
APPRECIATED BY ALL.
I'LL CALL AN AUDIBLE AND TAKE A
QUICK BREAK.
LET'S GET BACK AT 3:05.
THAT GIVERS YOU JUST ABOUT 15 MINUTES.
I'LL SEE YOU IN A MINUTE. >> STILL IN THE PUBLIC PART?
>> YES. >> EXCELLENT.
THANKS.
WE'RE NOW GOING TO MOVE INTO
CONCEPT CLEARANCE PORTION
REQUIRED BY POLICY TO PRESENT
CONCEPTS PUBLICLY,ED THAT WE
HAVE -- TODAY WE HAVE ONE.
I'LL TURN IT OVER TO DR. RANDY
KING, ULTRASOUND PROGRAM
DIRECTOR, DIVISION OF APPLIED
SCIENCE AND TECHNOLOGY, TO
PRESENT A CONCEPT ON REISSUE OF
NIBIB TRAILBLAZER.
>> THANKS, ANNA.
THANK YOU FOR GIVING ME THE
OPPORTUNITY TO DISCUSS THE
RESHARE OF THE TRAILBLAZER.
BEFORE I START I WANT TO THANK
THE NIBIB DATA TEAM PARTICULARLY
JENNIFER JACKSON WHO VERIFIED
DATA AND ITS PRESENTATION.
THE TRAILBLAZER IS DUE TO
EXPIRE, IT'S AN R21 MECHANISM
THAT BEGAN WITH NIBIB, OPEN ONLY
TO NEW INVESTIGATORS, MINIMAL
AMOUNT OF PRELIMINARY DATA IS
ALLOWED, $400,000 IN DIRECT
COST, THREE YEARS, AS WITH ALL
R21 NOT RENEWABLE.
NIBIB ISSUED IN 2017, CAME ABOUT
AS A RESULT OF WORKING WITH
COUNCIL, TASK FORCE THAT WAS LED
BY BRUCE TROMBERG, THEN COUNCIL
MEMBER, FORMED INTO RESPONSE
FROM SEVERAL CONDITIONS WE RAN
INTO AT THAT TIME.
AROUND 2015 WE WERE SUFFERING
FROM FALLEN PAYLINE.
R01 AND R21 PAY LINES WERE TIED
TOGETHER, R01 APPLICATIONS
REMAINED STEADY, RESULTING IN WE
WERE CONCERNED THAT THE R01
COULD TAKE OVER THE NIBIB
BUDGET, THE PROVERBIAL WEED IN
THE BUDGETARY GARDEN.
DATA AT THAT TIME, THE TASK
FORCE, WE FOUND THAT WITH THE
R21 ESTABLISHED INVESTIGATORS
ARE OUTCOMPETING EARLY STAGE
INVESTIGATORS, SO FUNDING FOR
ESTABLISH WAS TWICE THE RATE OF
EARLY STAGE, AROUND 60% OF R21
SUBMISSIONS WERE EARLY STAGE,
40% OF R21 AWARDS WERE MADE TO
EARLY STAGE INVESTIGATOR.
SO AS YOU CAN POSSIBLY PREDICT
ESTABLISHED INVESTIGATORS ARE
SCORING BETTER ON R21
APPLICATIONS.
ONE SOLUTION WAS WITHDRAWING
FROM R21 TOGETHER.
WE FOUND R21 DOES HAVE VALUE
ESPECIALLY EARLY STAGE
INVESTIGATOR COMMUNITY.
PATENT AND PUBLICATION METRICS
IN R21 OUTPERFORMED R01s, R21
ATTRACT UNIQUE COMMUNITY FROM
STEM FIELDS AND PARTICULARLY
NIBIB WE'RE IN A POSITION TO
BRING IN INVESTIGATORS FROM
PHYSICAL SCIENCE AND
COMPUTATIONAL FIELD IN AREAS
THAT MIGHT HAVE GOTTEN NIH
FUNDING, WE SAW FOR NEW
INVESTIGATORS, EARLY STAGE
INVESTIGATORS R21s DOUBLED
LIKELIHOOD OF GETTING R01, ONE
OF THE PRIORITIES TO GET THAT
INVESTIGATOR INTO THE R01.
WE CAME ONE A THOUGHTFUL
APPROACH, MANAGING R21 PORTFOLIO
SPENDING, WE DID THAT PARTLY BY
DISASSOCIATES R01 R01 PAYLINE R
2.
WHAT THAT MEANS IS R21, THEY
DON'T GET A PERCENTILE PUBLISHED
ON SUMMARY STATEMENT, WE TAKE
SEVERAL CRITERIA INTO ACCOUNT
WHEN WE AWARD THE R21, INCLUDING
REVIEW SCORE, WEIGHTED HEAVILY
BUT WE LOOK AT OTHER CRITERIA
SUCH AS NOVELTY OF RESEARCH,
PRIORITIES OF THE INSTITUTE, AS
WELL AS INVESTIGATOR.
WE REALLY WANTED TO RETURN TO
THE ORIGINAL INTENT OF THE R21.
AT THIS TIME A LOT WERE
RESEMBLING SMALL R01s WHICH
WASN'T THE SPIRIT OF THE R21,
REALLY FORETHAT UNIQUE NOVEL
EXPLORATORY NON-INCREMENTAL TYPE
OF RESEARCH.
WE WANTED TO GET BACK TO THAT.
WHEE WANTED TO INITIATE THESE,
WE WANTED TO MAKE SURE WE DIDN'T
IMPACT THE YOUNG INVESTIGATOR IN
A NEGATIVE WAY.
THE TRAILBLAZER IS ONLY OPEN TO
NEW INVESTIGATORS, AND WHILE
PRELIMINARY DATA IS NOT REQUIRED
OR EVEN EXPECTED, A MINIMUM
AMOUNT IS ALLOWED, HALF A PAGE
OF PRELIMINARY DATA WHICH CAN
INCLUDE UP TO ONE FIGURE,
$400,000 DIRECT COST, THREE
YEARS, COMPARED TO PARENT R21,
OPEN TO EVERYONE, $275,000
DIRECT COST, TWO YEARS, YOU SEE
THE TRAILBLAZER IS SUBSTANTIALLY
MORE MONEY AND MORE TIME.
WHAT WAS THE IMPACT?
LOOK AT THE PLOT.
THIS IS THE NUMBER OF
APPLICATIONS OVER TIME FROM 2019
TO 2024, THE FIRST FULL YEAR WE
HAD DATA FOR.
TRAILBLAZER CAME OUT IN MAY OF
2017, SO IT WASN'T OUT FOR A
FULL
YEAR UNTIL 2018, AND PEAKED IN
THAT TIME FRAME.
AFTER THAT WHEN WE INITIATED
TRAILBLAZER WE HELPED CONTROL
NUMBER OF R21 WE WERE BRINGING
INTO THE INSTITUTE.
AT THE SAME TIME LOOKING AT R01
APPLICATIONS ON THE PLOT IT
REMAINED STABLE, HOVERING AROUND
600 APPLICATIONS.
SO DOES SEEM THAT THE
TRAILBLAZER AND THESE OTHER
INTERVENTIONS WERE ABLE TO
CONTROL THE NUMBER OF R21s WE
BROUGHT INTO THE INSTITUTE, NOT
AFFECTING R01s.
WHAT ABOUT THAT YOUNG
INVESTIGATOR, THE R21 HELPED?
DATA FROM 2015.
WE AWARDED 85 NEW R21s, 16
EARLY STAGE INVESTIGATORS.
LAST CAREER 2024 AWARDED 63 NEW
R21s, 10 TO THE PARENT, 30
TRAILBLAZERS, ALL NEW
INVESTIGATORS.
18% OF R21 AWARDS OR ESIs
BEFORE WE STARTED THE
TRAILBLAZER, NOW 63% OF OUR
AWARDS ARE THE YOUNG
INVESTIGATOR WHICH MEANS WE'VE
HAD 26% DECREASE IN NUMBER OF R
21 AWARDS, 150% INCREASE IN
NUMBER OF FUNDED EARLY STAGE AND
NEW INVESTIGATORS.
DOES SEEM WE'RE ABLE TO
ACCOMPLISH OUR GOAL PROTECTING
NIBIB PAYLINE, REDUCE NUMBER OF
R21 AWARDS, AND WASN'T AT THE
COST OF THE NEW INVESTIGATORS,
WE DID THE OPPOSITE, HELPED MORE
NEW INVESTIGATORS WITHOUT --
WHILE REDUCING R21 AWARDS, THE
TRAILBLAZER WAS A HUGE FACTOR
BUT WASN'T FREE.
ISSUING A NEW R21 MECHANISM THAT
ONLY WE PARTOOK IN DID COME AT
SOME COST.
A LOT WAS GETTING THIS NEW
MESSAGE TO THE COMMUNITY, NOT
JUST COMMUNITY IN TERMS OF
SCIENTIFIC COMMUNITY BUT ALSO
PROGRAM COMMUNITY, NIH, REVIEW
COMMUNITY AT NIH.
WE HAD TO GET IT ACROSS WE
WANTED TO GO BACK TO THE
ORIGINAL R21, NOVEL
NON-INCREMENTAL TYPE OF
PROJECTOR, WORKING INSIDE NIH
AND OUT HELPING EVERYONE
UNDERSTAND TERMS WE'RE USING
LIKE ESTABLISHED VERSUS NEW
VERSUS EARLY STAGE INVESTIGATOR
THAT HAS NOT SIGNIFICANT FUNDING
BEFORE, AND TEN YEARS OF
TERMINATION DEGREE.
A NEW IS SOMEONE WHO HASN'T HAD
SIGNIFICANT RESEARCH FUNDING
BEFORE, NO TERMINATION DEGREE
CRITERIA PUT UPON THEM.
AND TO MY KNOWLEDGE, THIS IS
ONLY ONE OF TWO MECHANISMS THAT
USE THE DISTINCTION OF NEW
INVESTIGATOR SO WE HAD TO SPENDS
TIME EXPLAINING WHAT WE WANTED,
WHAT THE POINT WAS.
R21 WE LIMIT PRELIMINARY DATA.
ONE OF THE BIGGEST HURDLES WAS
DEFINE PRELIMINARY DATA, THE
MOST BINARY DEFINITION WAS
SIMPLY DATA THAT HAS NOT BEEN
PUBLISHED.
WE HAD TO GET THE MESSAGE OUT TO
REVIEW, WORK WITH SROs TO
UNDERSTAND THE NEW MECHANISM.
AT FIRST TRAILBLAZERS WERE
ASSIGNED SPECIAL REVIEW
SECTIONS, SO WASN'T AS HUGE OF
AN ISSUE BUT NOW WE HAD TO MAKE
SURE EVERY SRO UNDERSTAND
TRAILBLAZER AND WHAT WE WANT AND
WHAT'S EXPECTED.
WE HAD TO HOLD THE TRAILBLAZERS
TO THE SAME REVIEW STANDARD AS
REGULAR R21s, THOSE ARE NOT
R21-LIKE BECAUSE THEY ARE
LIMITED TO NEW INVESTIGATORS.
PRELIMINARY DATA WHILE NOT
EXPECTED IT IS ALLOWED.
HALF A PAGE, INCLUDING ONE
FIGURE.
THAT'S AN ELIGIBILITY CRITERIA,
WHEN SOMEONE SUBMITS
APPLICATION, THAT HAS TO BE
ASSESSED.
IT IS ASSESSED BY PROGRAM BEFORE
IT GOES TO REVIEW.
WE WERE WORRIED AT FIRST THIS
WOULD BE ONEROUS TO OUR STAFF
AND BE A LOT OF WORK, BUT OUR
STAFF QUICKLY LEARNED HOW TO
REVIEW APPLICATIONS, PRESENCE OF
PRELIMINARY DATA, MORE
INDICATION OF SKILL AND
DEDICATION OF PROGRAM STAFF THAN
ANYTHING ELSE BUT ALSO WORRIED
ABOUT DELAYS GETTING TO REVIEW,
THAT HAS NOT PROVED TO BE AN
ISSUE.
WHAT HAS BEEN AN ISSUE IS NUMBER
OF WITHDRAWALS.
TRAILBLAZER DOES INCREASE NUMBER
OF WITHDRAWALS AT NIBIB,
TRAILBLAZER MECHANISM ESPECIALLY
WITH BEING THE OWN ONE ON IT AT
THIS POINT IN TIME WE CANNOT
TRANSFER A GRANT TO ANOTHER
INSTITUTE IF IT'S NOT A MISSION
FIT FOR NIBIB, BECAUSE COMPARED
TO THE PARENT R21S THEY ARE
ASKING FOR MORE MONEY, MORE
TIME, DOESN'T FIT ANYWHERE ELSE.
WHY IT'S IMPORTANT TO TALK TO
PROGRAM OFFICIALS BEFORE THEY
APPLY WE CAN HELP KEEP THE
NUMBER OF WITHDRAWALS DOWN TO A
MINIMUM.
NOW NIBIB THIS ISN'T THE ONLY
MECHANISM WHERE WE HELP YOUNG
INVESTIGATOR.
WE HELP WITH THE PARENT.
LAST YEAR BOTTOM LINE WERE ABLE
TO GET A NEW INVESTIGATOR FIVE
POINT PAYLINE BUMP, FIVE
PERCENTAGE POINT PAY LINE BUMP,
EARLY STAGE INVESTIGATOR 13%
HIGHER PAYLINE.
WE ALSO DID PARTICIPATE IN THE
CAT MECHANISM THAT DIDN'T
-- NOT
CURRENTLY.
WHEN WE STARTED IT WAS A NIBIB
R21 MECHANISM.
AGING JOINED US QUICKLY,
NATIONAL EYE INSTITUTE JOINED
THEREAFTER, AND SINCE WE ISSUED
IN 2025 IT'S BEEN THESE THREE
I.C.s ON IT, QUICKLY GROWING,
WITH THE REISSUANCE NCI,
NATIONAL CANCER INSTITUTE,
NATIONAL INSTITUTE OF CHILD
HEALTH AND DEVELOPMENT, NATIONL
CENTER FOR INTEGRATIVE HELP WILL
JOIN US.
LAST RECEIPT DATE IS NOVEMBER OF
THIS YEAR.
SO WE ISSUE FOR JANUARY 2026
RECEIPT DATE, OTHER THAN THAT
NOTHING, WE DON'T FIND ANY OTHER
CHANGES TO THE MECHANISM, IT
WILL STILL BE AN R21, LIMITED TO
NEW INVESTIGATOR, STILL LOOKING
FOR THE PROJECT THAT DIFFERS
FROM CURRENT THINKING, THAT CAN
BE TECHNOLOGY, DESIGN,
DISCOVERY, HYPOTHESIS DRIVEN.
PRELIMINARY DATA IS STILL NOT
REQUIRED, EXPECTED, ENCOURAGED,
BUT ALLOWED, CAN INCLUDE ONE
FIGURE, ONE PAGE, $400,000
DIRECT COST, THREE YEARS.
THAT'S A BRIEF HISTORY OF OUR
TRAILBLAZER AND CURRENT PLANS
FOR CONTINUATION, SO INVITE
QUESTIONS YOU MAY HAVE.
>> THANKS, RANDY.
QUESTIONS OR COMMENTS FOR RANDY?
BRUCE?
>> I LOVE THE TRAILBLAZER.
>> YEAH, WE THINK IT'S REALLY
MEETING THE IMPORTANT NEED,
OBVIOUSLY, THE DATA ARE SHOWING
THAT QUITE CLEARLY.
SO, RANDY, YOU SORT OF -- DID
YOU MENTION THE KATZ AWARD?
IS THAT GOING TO COME BACK?
MAYBE YOU COULD HELP PEOPLE SEE
THE RELATIONSHIP BETWEEN THE TWO
AND MAYBE SAY A FEW WORDS ABOUT
THAT.
>> THE KATZ AWARD WAS TERMINATED
BASED ON NEW REVIEW CRITERIA, IT
IS IN THE WORKS, HAS NOT HIT THE
STRAIGHT, NOT PUBLIC, NOT OUT
YET.
WE HAVE HOPES IT WILL REEMERGE.
IT IS FOR THE EARLY STAGE
INVESTIGATOR, AN R01 MECHANISM,
AND NO PRELIMINARY DATA IS
ALLOWED, A NEW RESEARCH AREA
THAT HAS TO BE STATED WHY THIS
WORK IS A NEW DIRECTION FOR
THEM.
PRELIMINARY DATA IS ELIGIBILITY
CRITERIA, REVIEWED BEFORE
REVIEW.
THE P.I. NEEDS TO SAY WHY IT'S A
NEW DIRECTION AND CONVINCE THE
REVIEW PANEL.
WE HOPE IT WILL COME BACK.
>> FOR NOW, THIS MOVES FORWARD,
THIS IS AS IT STARTED WAS REALLY
THE ONLY MECHANISM AT THE NIH
THAT HAD THIS KIND OF UNIQUENESS
FOR EARLY STAGE INVESTIGATORS,
AND ALSO THE RECOGNITION THAT
VIRTUALLY ALL OF OUR R21s
ASKED FOR, YOU KNOW, THE
TWO-YEAR R21s WANTED A ONE
YEAR NO COST TIME EXTENSION SO
KIND OF AN ACKNOWLEDGMENT THAT
THERE'S INTRINSIC TIME BLOC OF
THREE YEARS.
SO IT JUST SEEMED QUITE
APPROPRIATE.
>> ABSOLUTELY.
KATZ MECHANISM TOO BORROWED FROM
OUR TRAILBLAZER, SUCCESS OF OUR
TRAILBLAZER REALLY HELPED TO
BUILD THE KATZ.
>> I'M INTERESTED IN, YOU KNOW,
COUNCIL MEMBERS' THOUGHTS ON WE
WERE ALSO HOPING THAT THE
TRADITIONAL PRESTIGE, TENURE
PROMOTION MEASUREMENT POINT HAS
BEEN AN R01, WE WERE KIND OF
HOPING THAT THE R21 TRAILBLAZER
WITH BOTH THE NAME AS WELL AS
THE THREE-YEAR DURATION, A
LITTLE MORE MONEY, WOULD BEGIN
TO EMERGE AND TENURE AND
PROMOTIONS DISCUSSIONS AS AT
LEAST HIGH LEVEL, HIGH VALUE
CURRENCY, HIGHER THAN A TWO-YEAR
R21 LET'S SAY.
SO HAVE YOU SEEN TRENDS IN THAT
DIRECTION OR IS IT NEUTRAL?
>> YEAH, I GUESS I'D SAY WHAT
I'VE SEEN AS A TREND TOWARDS
INCORPORATING, YOU KNOW, MORE
AND MORE FORMS OF FUNDING, AND I
THINK THE TRAILBLAZER WITH A
LONGER TERM AND SORT OF, YOU
KNOW, CATCHY TITLE COUNTS IN
THAT CATEGORY.
I THINK THERE WAS SORT OF A
SINGULAR ATTENTION ON R01s FOR
A NUMBER OF PRETTY UNCOMFORTABLE
YEARS.
AT LEAST AT OUR INSTITUTION I
THINK THAT'S STARTING TO SHIFT,
AND I CAN ONLY ANTICIPATE THAT
THAT WILL SHIFT STILL FURTHER IN
TIMES TO COME.
SO I THINK GIVING YOUNG
INVESTIGATORS A CHANCE LIKE THIS
IS AND CONTINUES MORE TO BE AN
IMPORTANT THING.
>> THANKS, DO YOU HAVE A
QUESTION?
>> I WAS GOING TO SAY THE SAME
THINK, MOVING AWAY FROM THE R01,
MORE WHAT YOU CAN DO WITH THE
DURATION AND SCOPE OF THE
PROJECT.
>> WILBUR?
>> I AGREE.
ONE ADDITIONAL THING, THERE'S A
LOT OF BENEFIT THAT OTHER
I.C.s ARE JOINING IN ON THE
TRAILBLAZER BECAUSE THAT MAKES
YOUR BRAND THAT MUCH BETTER
BECAUSE OBVIOUSLY NOT EVERY P.I.
WILL BE ELIGIBLE FOR THE NIBIB
ONE.
BUT THIS WAY, THE MORE I.C.S ARE
JOINING IN AND IF THEY ARE
REISSUING THAT'S A GREAT THING,
IF YOU KNOW THEY ARE DOING THAT
BECAUSE IT MAKES FOR MORE BRANDS
AWARENESS.
>> AND GIVEN THE CLIMATE, HOW
IT'S CHANGING, WE STILL HAVE
TIME BEFORE THIS HAS TO GET OUT
I WILL CONTINUE WORKING WITH
OTHER I.C.s TO GET MORE SIGNED
ON AS WELL, THAT'S ONE OF OUR
GOALS.
>> I WONDER, JUST IN ADDITION IF
THERE MIGHT BE SOME WAY, MAYBE
YOU'RE ALREADY DOING THIS, TO
REALLY HIGHLIGHT THE
TRAILBLAZERS IN SOME FORUM?
BECAUSE I THINK THEN THAT WILL
ELEVATE THE STATURE AND MAKE IT
SEEM LIKE A NEW INNOVATOR AWARD
BUT JUST IN A DIFFERENT SCALE.
>> A QUICK FOLLOW-ON, REMINDS ME
WATCHING THE TRAJECTORY OF THE
NSF CAREER AWARD OVER TIME, WENT
FROM BEING JUST A THING TO
SOMETHING THAT EVERYBODY
RECOGNIZED AS HIGHLY
PRESTIGIOUS.
TRAILBLAZER CERTAINLY HAS THE
SAME LINGUISTIC FEEL, YOU KNOW,
AND SO ACTUALLY HIGHLIGHTING
THAT, I AGREE CAN ONLY HELP.
>> YEAH I WANTED TO ECHO WHAT
DAN SAID.
WITHIN OUR DEPARTMENT WE'VE
HIGHLIGHTED THE TRAILBLAZER TO
BE SOMEWHAT OF EQUIVALENT OF THE
CAREER AWARD BECAUSE SO MANY OF
OUR FACULTY DON'T NECESSARILY
FALL INTO THE TYPICAL CAREER
AWARD CATEGORIES, AND SO ARE
MORE GET ACTIVE FOR THE
TRAILBLAZER.
SO I KNOW WE'VE GONE FORWARD TO
COLLEGE OF ENGINEERING TO SAY,
NO, YOU DON'T HAVE TO HAVE --
THEY LOOK FOR CAREER, CERTAINLY
AND R01 BUT WE'RE PAINTING THIS
IN THE BIOMEDICAL SPACE, SO THE
NAME CERTAINLY CARRIES THAT
WEIGHT.
IT'S HELPING OUR PROGRAM.
THANK YOU.
>> THANKS SO MUCH.
>> NOT TO PLAY DEVIL'S ADVOCATE,
IF THE PIPELINE BRINGS IN MORE
AND MORE NEW INVESTIGATORS, HOW
ARE WE GOING TO SUPPORT THEM ALL
WHEN THEY HAVE BECOME
ESTABLISHED INVESTIGATORS?
I'M LOSING MY VOICE TOO.
JUST THOUGHTS HOW WE BALANCE
THAT PIPELINE AS WE GO THROUGH.
>> A CONTINUING BATTLE DEPENDING
WHERE THE BUDGETING RESTS NEXT
YEAR.
I'LL THROW THAT TO BRUCE FOR
FURTHER COMMENT.
>> THAT WAS YOUR CUE.
>> YEAH, THAT WAS YOUR CUE.
>> HOW COME I GET THE HARD
QUESTIONS?
SO, YEAH, FROM ALL THE STATS
FROM, THE NUMBER ONE CASUALTIES
ARE THE EARLY-STAGE
INVESTIGATORS, NOT THAT THE
MIDDLE STAGE IS ALSO VULNERABLE,
I MEAN, ABSOLUTELY VULNERABLE,
BUT KIND OF THE BIGGEST IMPACT
IN DROPOUT THAT THE DATA, YOU
KNOW, MIGHT -- WHILE WE DID A
WONDERFUL JOB PRESENTING OVER
THE YEARS, SO I THINK THIS WAS
IN PART IN RESPONSE TO THE
PAYLINE DROPPING DOWN TO 8th
PERCENTILE WHICH COULD GO TO
AGAIN WITH OTHER BUDGETARY
MACHINATIONS THAT COULD BE
COMING SO WE'RE TUNED IN TO ALL
THESE PROBLEMS AT THE SAME TIME
AND LOOK FORWARD TO YOUR
SUGGESTIONS.
AND, YOU KNOW, MAYBE WE HAVE TO
HAVE ANOTHER TASK FORCE TO
ADDRESS IT BUT THE PROBLEM IS
STILL MOVING RIGHT NOW.
SO WE HAVE SOME VISIBILITY ON
EARLY STAGE INVESTIGATORS
VULNERABILITY.
TO CHRISTINE'S POINT ABOUT THE
VALUE OF PROMOTING, WE ARE
NATURALLY INTERCONVERTIBLE BEEN
ENGINEERING AND MEDICINE
CULTURES, BUT THERE ARE SCHOOLS
OF ENGINEERING AND SCHOOLS OF
MEDICINE WITH DIFFERENT CULTURAL
VALUATION AND APPROACHES TO
THESE NAMES AND AWARDS, AND, YOU
KNOW, LIKE IN MEDICINE IT'S A
BIGGER LEAP TO PLACE HIGHER
VALUE ON R21, EVEN THOUGH IT'S
TRAILBLAZER.
AS OPPOSED TO R01, IT'S LIKE
SOMEHOW TRULY BUILT INTO
CONSCIOUSNESS SO WE HAVE TO WORK
TOGETHER AS A COMMUNITY AND SO
FOR ALL OF YOU WHO ARE KIND OF
PUTTING EFFORTS TOGETHER TO DRAW
ATTENTION TO IT, WORK WITH US,
HELP KIND OF REINFORCE THIS
MESSAGE BUT I THINK IT'S JUST A
WONDERFUL IDEA TO PROMOTE THIS.
I THINK SCHOOLS OF ENGINEERING
WILL BE MORE WILLING BECAUSE
THEY TEND TO, YOU KNOW, EXPECT
LOWER FUNDS EVEN THAT THEY ARE
MAKING A BIGGER DEAL OVER FROM
SMALLER GRANTS, WITH PRESTIGE.
SO THIS IS I THINK A BIG
OPPORTUNITY TO HELP ADVANCE THE
ENGINEERING/MEDICINE
PRIORITIZATION AND WHEN DEANS
TALK TO THEIR COLLEAGUES IN
MEDICINE IT'S CONTAGIOUS, DEANS
OF ENGINEERING CAN HELP CONVINCE
DEANS OF MEDICINE THIS IS A
REALLY, REALLY GOOD AND
IMPACTFUL THING.
SO I THINK WE HAVE TO BAND
TOGETHER TO HELP ADVANCE AND
PROMOTE THIS.
THIS IS A BRIGHT SPOT.
WE'RE LOOKING FOR BRIGHT SPOTS.
THIS IS A BRIGHT SHOT -- SPOT N
OUR COMMUNITY SO WORK WITH US TO
GET THIS MESSAGE OUT AND HELP
PROMOTE.
CYNTHIA, WE MAY HAVE ANOTHER
TASK FORCE COMING.
I DON'T KNOW.
I ACTUALLY HOPE NOT.
YOU'VE SEEN THE WHITE HOUSE
BUDGET.
>> AND THE LAST WORD.
>> YEAH, A QUICK QUESTION.
I MEAN, BASED ON THE FUNDING YOU
HAD IN 2024 WAS THIS THE RIGHT
BALANCE YOU THOUGHT BETWEEN THE
R01s AND OTHER MECHANISMS AND
TRAILBLAZER?
I WANT TO GET A FEELING FOR HOW
YOU FELT THE NUMBERS WORKED, AT
LICE -- AT LEAST WHEN YOU HAD
THE MONEY IN 2024.
THAT MAY CHANGE GOING FORWARD.
>> A QUESTION FOR ME, RANDY, OR
DAVE?
>> FOR ANYBODY WHO WANTS TO
ANSWER IT.
BUT, YEAH, I'M NOT SURE.
BRUCE, MAYBE YOU CAN TAKE IT, OR
WHOEVER MIGHT BE IN THE BEST
POSITION.
>> THAT WAS MY RHETORICAL
QUESTION LOOKING AT DAVE.
>> WE SUCCESSFULLY MAINTAINED
FROM LAST YEAR TO THIS YEAR THE
NUMBER OF AWARDS, R01s AND
TRAILBLAZERS AND THE PARENTS.
SO, WE GOT A LITTLE BIT.
BRUCE MENTIONED HOW WE HAD FEWER
CUTS THIS YEAR.
SO BARRING ANY CHANGES STARTING
TODAY GOING FORWARD, WHICH ARE A
POSSIBILITY, WE WERE OPERATING
WITH THE SAME BUDGET AS LAST
YEAR SO WE WERE ABLE TO KIND OF
LEVEL OFF THE NUMBER OF R21s
AND R01s AND KEEP THEM
BALANCED WITH LAST YEAR.
AS RANDY POINTED OUT, THE
TRAILBLAZER WAS CARVED OUT, THE
PORTFOLIO WAS $20 MILLION
SUPPORTING 80-SOMETHING
TRAILBLAZERS, THE R01 IS $200
MILLION-ISH DOLLARS SUPPORTING
300-ISH R01s, WE'VE BEEN ABLE
TO MAINTAIN THOSE NUMBERS IN THE
FACE OF THE CURRENT CHANGES SO
FAR.
>> OKAY.
SO, HEARING SUPPORT FOR THIS
PROGRAM WE'LL MOVE FORWARD TO
CONTINUE TO DEVELOP THIS CONCEPT
AND HOPEFULLY YOU'LL STAY ON THE
STREETS AND WE'LL SEE THIS IN
THE FUTURE.
THANK YOU.
THANK YOU, RANDY.
>> THANK YOU.
>> AND OUR LAST ORDER OF
BUSINESS IN THE OPEN SESSION,
WE'LL HEAR FROM TODD MERCHAK,
DIRECTOR OF OFFICE OF EVALUATION
AND STRATEGIC PARTNERSHIPS.
THIS IS ALSO RESIDUAL FROM
JANUARY MEETING WHERE TODD IS
GOING TO TALK ABOUT THE NIBIB
RADx PROGRAM YOU'VE HEARD A
LOT ABOUT, SORT OF NIBIB-LED
EFFORT CRITICAL TO NIH'S
RESPONSE TO THE COVID-19
PANDEMIC.
WE'LL HEAR FROM TODD TODAY,
SOMETHING DIFFERENT, BEHIND THE
SCENES LOOK AT RADx PLATFORM
AND DETAILS ON EXECUTION AND
POSITIONED TO BE ON TECHNOLOGY
ACCELERATOR PLATFORM IN THE
FUTURE.
WE'LL HEAR HOW RADx IS
POSITIONED, IN A WAY THAT
AMPLIFIES THE INSTITUTE'S
IMPACT.
WITH THAT I WILL TURN IT OVER TO
TODD.
>> THANK YOU, ANNA.
APPRECIATE EVERYONE'S TIME AND
ATTENTION TODAY.
YOU'VE HEARD ABOUT THE RADx
INITIATIVE OVER THE PAST FEW
YEARS, EARLIER THIS AFTERNOON.
I'D LIKE TO TAKE THIS
OPPORTUNITY TO DELVE DEEPER INTO
HOW WE'RE ABLE TO ACCELERATE
TECHNOLOGY DEVELOPMENT AS WELL
AS TOUCH ON OUR VISION FOR
POSITIONING RADx AS
SUSTAINABLE AND VALUE-DRIVING
RESOURCE FOR THE FUTURE.
IN SHORT, AS THE TITLE SUGGESTS,
CREATE TECHNOLOGY AND
ACCELERATION PLATFORM.
FORGED UNDER THE DURESS OF THE
NATIONAL EMERGENCY, THE
PANDEMIC, CAN NEED FOR ACCURATE
TESTING SEEMED OVERWHELMING AT
THE START.
WITH THE VIRUS SPREADING RAPIDLY
TIME WAS NOT ON OUR SIDE.
RADx WAS FORTUNATE ENOUGH TO
HAVE RECEIVED AMPLE FUNDING
WHICH WE FELT CONFIDENT WOULD
ALLOW US TO SCALE OUR EFFORT TO
BRING TESTS TO THE MARKET.
WHAT WAS UNCLEAR WAS HOW WE WERE
GOING TO ACCOMPLISH THIS ON SUCH
AN ACCELERATED TIME SCALE.
ANYONE THAT HAS WISHED THEY
COULD SQUEEZE ONE MORE HOUR INTO
THE DAY KNOWS THE FEELING.
WHAT THAT I HAD THIS TIME
PRESSURE ACUTE FOR US WAS THE
UNDERSTANDING THAT UNDER TYPICAL
CIRCUMSTANCES DIAGNOSTIC TESTS
REQUIRED THREE TO FIVE YEARS OF
DEVELOPMENT AND REGULATORY
STUDIES TO REACH THE MARKET.
AND WE'RE BEING ASKED TO ACHIEVE
THE SAME FEAT IN MONTHS.
SO AS WE LOOK AT THIS OVERVIEW
SLIDE TODAY AND TAKE NOTE OF THE
OUTCOME MEASURES WHICH I SHOULD
ADD EXCEEDED OUR OWN
EXPECTATIONS BRINGING 8 BILLION
POINT OF CARE AND OVER THE
COUNTER TESTS TO THE PUBLIC AND
SHIFTING THE PARADIGM FROM
CENTRAL LABS WHILE WE HAD FAITH
IN THE APPROACH SUCCESS WAS NOT
PRE-DETERMINED BY ANY MEANS.
WE ALL UNDERSTOOD FAILURE WAS
NOT REALLY AN OPTION.
BUT DRAMATICALLY REDUCING TIME
TO MARKET FOR THESE TYPES OF
DIAGNOSTIC TECHNOLOGIES HAD
NEVER BEEN DONE.
NOW ONE OF THE ADVANTAGES WE
HAD, WHY NIBIB WAS PARTICULARLY
POISED TO ATTEMPT SUCH A FEAT
WAS THE ESTABLISHMENT AND GROWTH
OF THE POINT-OF-CARE TECHNOLOGY
RESEARCH NETWORK, POCTRN.
POCTRN LAUNCHED IN 2007, GAINED
OVER A DECADE OF EXPERIENCE IN
THE TREND.
[ NO AUDIO ]
>> YOU'RE GOOD.
I THINK YOU'RE GOOD.
>> AM I GOOD?
>> YEAH.
>> OKAY.
APOLOGIES.
SO THESE KEY CAPABILITIES AND
EXPERTISE THAT WERE DEVELOPED
OVER TIME ENDED UP BEING
INVALUABLE TO THIS RAPID
RESPONSE EFFORT.
AND UNDER THE GUIDANCE OF THE
POCTRN COORDINATING CENTER,
CIMIT, COLLECTIVE EXPERTISE
SHAPED THE DESIGN OF THE
INNOVATION FUNNEL MODEL, KEEN
EYE TOWARD MAXIMUM ACCELERATION.
AND GIVEN THE CONSTRAINTS WE
WERE UNDER THOUGH I THINK IT'S
WORTH POINTING OUT THE CREATION
OF THE RADx PROCESS WAS NOT
INVENTION OF SOMETHING NEW AND
UNIQUE, RATHER LARGELY AN EFFORT
TO INTEGRATE BEST PRACTICES FROM
INDUSTRY, ACADEMIA, GOVERNMENT,
AND REALLY TO LEVERAGE AVAILABLE
RESOURCES AND PROFESSIONAL
NETWORKS.
POCTRN ALLOWED US TO EXERCISE
STRENGTHS WE HAD BEEN BUILDING
AND PIVOT AND AMPLIFY IN A TIME
OF URGENCY AND NEED.
WE HAD THE OPPORTUNITY TO
ANALYZE OUTCOMES AND REFLECT ON
THE STRUCTURES AND WORKFLOWS
IMPLEMENTED, WE'VE COME TO
BETTER UNDERSTAND KEY FEATURES
OF THE RADx MODEL THAT
CONTRIBUTED TO THIS ACCELERATED
PACE WE ACHIEVED.
SO MANY COMPONENTS MIGHT BE
FAMILIAR, USED IN MANY SIMILARLY
STRUCTURED TRANSLATIONAL
PROGRAMS.
HOWEVER, I WOULD LIKE TO WALK
THROUGH EACH IN A BIT MORE
DETAIL TO BETTER EXPLAIN HOW AT
NIBIB WE RECORDED THESE
ACTIVITIES INTO A MORE
CUSTOMIZED SERVICES THAT CAN
SUIT NEEDS OF TECHNOLOGY
DEVELOPMENT EFFORTS.
AND REALLY AS MENTIONED IN THE
TITLE OF THIS TALK, TO POSITION
RADx AS A PLATFORM FOR
TECHNOLOGY TO DRIVE BEYOND THE
PANDEMIC.
FLEXIBLE CONTRACTING VEHICLES
CAN SCALE TO CHANGING AND FUTURE
REQUIREMENTS.
AND SO I WOULD LIKE TO
ACKNOWLEDGE THE UNWAVERING
SUPPORT FROM OUR COLLEAGUES IN
NHLBI OFFICE OF ACQUISITION TO
BRILLIANTLY AND TIRELESSLY WORK
TO ESTABLISH CORE STRUCTURES
THAT AFFORD US THIS FLEXIBILITY
AND CUSTOMIZATION THAT I'LL
DESCRIBE LATER IN THE
PRESENTATION.
SO IN THE RADx PROGRAM THESE
KEY FEATURES WERE ALL INTEGRATED
THROUGHOUT THE INNOVATION FUNNEL
PROCESS TO GENERATE SORT OF A
COMPOUNDING EFFECT TO ACCELERATE
THE PACE OF WORK.
INTENSIVE RISK ASSESSMENT IS A
BASELINE COMPONENT OF INVESTING
PLATFORM, RADx LOOKED TO
INDUSTRY AND VENTURE CAPITAL
MODELINGS TO CREATE EVALUATION
FOR SPEED AND FOR ROBUSTNESS.
THIS IS ENCAPSULATED
BIOGRAPHICAL WHEEL IN THE SLIDE
THAT DEPICTS FRAMEWORK CREATED
BY COLLEAGUES AT CIMIT FOR
MEASURING ACROSS THE PRODUCT
LIFE STILLING, TEN MATURITY
LEVELS ADAPTED FROM TECHNOLOGY
READINESS LEVELS, FOUR DOMAINS,
TECHNOLOGY, REGULATORY, MARKET,
BUSINESS, CLINICAL REPRESENT
EXECUTION VERTICALS THAT NEED TO
BE BALANCING TO ENSURE
COMPREHENSIVE DE-RISKING AND
MARK THE MILESTONES WITH EACH
DOMAIN AND LEVEL.
DETAILS SUNSHINE VISUALIZED
THROUGH UNDERLYING CHECK LIST
TEMPLATE, BRIEF DESCRIPTIONS OF
EACH MILESTONE, EACH PROJECT
TEAM COMPLETES THIS CHECKLIST AS
PART OF THE APPLICATION, A
BASELINE SELF-ASSESSMENT THAT
REVIEW TEAM CAN USE THROUGHOUT
DEEP DIVE PROS PROCESS AND THIS
BEEN A VITAL TOOL STREAMLINING
THE FUNNEL.
APPROACH CAN HELP ACCELERATE
TIMELINES ON TWO LEVELS,
PORTFOLIO LEVEL PROVIDES MORE
DETAILED RISK WEIGHTING THAT
SUPPORTS FUNDING DECISIONS, WE
CAN PRIORITIZE PROJECTS WITH
LOWER RISK PROFILE AND THUS
HIGHER POTENTIAL TO ACCELERATE.
AT THE PROJECT LEVEL IDENTIFYING
MOST HIGH RISK ISSUES UPFRONT
ALLOWS US TO BUILD MITIGATION
PLANS THAT DRIVE PROOF OF
CONCEPT FAST FASTER, WORK PLANS
ELIMINATE RISK, ADDING VALUE AND
SUSTAINING MOMENTUM, CRITICAL
ESPECIALLY IN EARLY STAGE
COMPANIES.
AND THIS MAKES PROJECTS MORE
ATTRACTIVE AND FOLLOW-ON FUNDING
WHETHER RADx OR PRIVATE
INVESTMENT.
ADDED A BENEFIT IS CREATES
FOUNDATION FOR ENTREPRENEURIAL
EDUCATION, THESE TIMES OF ROAD
MAPS ARE USED IN TRAINING
PROGRAMS LIKE I-CORPS, C3i TO
HELP BETTER UNDERSTAND AND
VISUALIZE ALL OF THE BARRIERS
THAT LIE AHEAD.
REMOVING BLIND SPOTS FROM
COMMERCIALIZATION PLANNING
PROCESS CAN MOTIVATE TEAMS TO
MOVE LESS CAUTIOUSLY AND MORE
DISEASIVELY THROUGH DEVELOPMENT
PIPELINE.
THIS MODEL OF CONTINUAL LEARNING
SAVES TIME AS PROJECT TEAMS GAIN
MORE KNOWLEDGE AND CAN SEE AHEAD
AT ANY GIVEN POINT.
MEANTORSHIP IS MODELS,
AMPLIFYING ENTREPRENEURIAL
ASPECT.
RADx RELIED ON A COHORT OF
INDUSTRY VETERANS WITH DECADES
OF EXPERIENCES IN THE LIFE
SCIENCE AND MED TECH FIELD,
ASSIGNED TO PROJECT TEAMS AND
ASSIST IN DEVELOPING MILESTONES,
TIMELINES, USING RISK ASSESSMENT
FEEDBACK WHILE ALSO ADDING THEIR
OWN PROFESSIONAL JUDGMENT.
IN PHASE 1 THE PROJECT MANAGERS
SERVE CRITICAL ROLE PROVIDING
LEADERSHIP AND GUIDANCE FOR THE
PROJECT, BOTH MENTORING TEAMS
AND ENTREPRENEURSHIP,
COMMERCIALIZATION, AS WELL AS
ENFORCING PROJECT SCHEDULES AND
TIMELY DELIVERABLES, RUN ROUTINE
ACCOUNTABILITY CALLS, A STAPLE
OF THE RADx MODEL,
INDISPENSABLE MAINTAINING PACE
OF ACTIVITY.
YOU CAN THINK OF THESE LIKE
SHERPA, TRY TO REACH THE
MOUNTAINTOP WITHOUT THEM BUT
WITH THE VAST KNOWLEDGE OF THE
LANDSCAPE AND PATHWAYS YOU'LL
HAVE A LESS PERILOUS JOURNEY
WITH THEM ON YOUR TEAM.
TEAMING UP WITH PROJECT MANAGERS
TO PROVIDE COMMUNICATIONS AND
LOGISTIC SUPPORT ARE PROJECT
FACILITATORS, YOUNG
PROFESSIONALS MOST OF WHOM
BIOMEDICAL ENGINEERING
UNDERGRADS, WHO FORMED THE GLUE
OF THE PROJECT TEAMS,
COORDINATING MEETINGS, TRACKING
ACTION ITEMS, INPUTTING
MILESTONE DATA, GAINING REAL
WORLD EXPERIENCE IN THE PROCESS.
TO COMPLETE THE CIRCUIT MANAGERS
SERVED ALONGSIDE THE PROJECT
TEAM PROVIDING GUIDANCE, PROGRAM
MANAGERS WERE KEY LIAISON POINT
CREATING LINKAGE.
IT'S HARD TO CONVEY HOW
IMPRESSED WE'VE BEEN WITH THE
CALIBER AND PROFESSIONALISM OF
PROJECT MANAGEMENT TEAMS, WE'VE
SEEN DEDICATION AND CREDIBILITY
INSPIRE TEAMS TO STRIVE FOR
AMBITIOUS TIMELINES, THEY MAY
NOT SEEM FEASIBLE, CAPTURING
ESSENCE OF RADx, PUSHING ONE
ANOTHER TO ACHIEVE SOMETHING NOT
PREVIOUSLY CONSIDERED POSSIBLE.
THE MODEL WAS DESIGNED TO BE
FAST TRACKED, UNLOCKED BY
MILESTONE ACHIEVEMENT.
PHASE 1 RAPID DE-RISKING IS
INTENDED TO LEAD PROJECTS TO
PERFORMANCE EVALUATION OF
PROTOTYPE, LARGER INVESTMENTS IN
PHASE 2 TO WORK QUICKLY, FROM
PORTFOLIO VIEW RISK IS BETTER
MANAGED AS MORE SUBSTANTIAL
RESOURCES CAN BE DEPLOYED, ONCE
WE HAVE CONFIRMATION OF
PERFORMANCE AS WELL AS
UNDERSTANDING OF TEAM'S ABILITY
TO EXECUTE.
TEAMS ACCEPTED INTO PHASE 2 ARE
EXPECTED TO BE NEARING DESIGN
LOCK, IN REPARATION FOR CLINICAL
STUDIES, RAMPING UP FOR PRODUCT
LAUNCH.
GREATER FUNDING AMOUNTS IN PHASE
2 HELPS TEAMS EXECUTE AT
ACCELERATED PACE WITH CERTAINTY
OF RESOURCES, PHASE 2 FUNDING
FOR FOR PRIVATE INVESTMENTS IN
MATCHED CONTRIBUTIONS, SHOWING
CREDIBLE VALUATION FOR
TECHNOLOGY AND THE TEAM.
SO THROUGHOUT PHASE 1 AND 2
TEAMS RECEIVED CUSTOMIZED
SUPPORT BASED ON PROFILE,
FILLING SKILLS GAPS AND GREAT
DEAL OF ACCELERATION IS GAINED,
CENTRALIZED VETTED VENDORS
PROVIDES EXPERTISE, PROVIDING
EXPERTISE IN QUALITY SYSTEMS,
DESIGN CONTROLS, SUPPLY CHAIN,
MANUFACTURING SCALEUP MARKETING
SALES, CONTRIBUTION, REGULATORY
CREATES ECONOMIES OF SCALE WHEN
APPLIED ACROSS MULTIPLE TEAMS IN
A PORTFOLIO AND THIS SUPPORT
FREES PROJECT TEAMS TO FOCUS ON
CORE COMPETENCIES TYPICALLY
TECHNOLOGY DEVELOPMENT WHILE
ALSO PROVIDING VALUABLE UPSTREAM
FEEDBACK ON POTENTIAL DOWNSTREAM
ISSUES.
ONE POIGNANT EXAMPLE IS
UNDERSTANDING COSTS,
MANUFACTURABILITY OF COMPONENTS
IN CURRENT DEVICE DESIGN,
CATCHING THAT EARLY CAN SAVE
TREMENDOUS AMOUNT OF MONEY AND
MONTHS OF EFFORT IN THE PROJECT.
CLINICAL REVIEW COMMITTEE WAS
ALSO ESTABLISHED AS PART OF THE
COMMERCIALIZATION CENTER WHERE
PROJECT TEAMS PRESENT
INSTRUCTIONS FOR USE WITH
DEVICE, COMMITTEE WOULD DRAFT A
REPORT DETAILING DESIGN
CONSIDERATIONS RELATED TO
USABILITY, UTILITY, AND WORK
FLOW FROM THE CLINICIAN'S
PERSPECTIVE.
THIS FEEDBACK GAVE DEVELOPERS
READY ACCESS TO END USER
EXPERTS, WHAT YOU CALL VOICE OF
CUSTOMER DATA, THAT PROVED TO BE
ANOTHER EXTREMELY VALUABLE
RESOURCE
RESOURCE WITH DESIGN.
INDEPENDENT VERIFICATION OF
VALIDATION IS A CORE TENET,
PROVIDING AN IMPORTANT
BELLWETHER ALONG THE DEVELOPMENT
PIPELINE.
THE VERIFICATION AND VALIDATION
CENTER WAS ESTABLISHED,
CENTRALIZED AND STREAMLINED THE
VALUATION FRAMEWORK WITH SUPPORT
FROM THE FDA PROTOCOLS WERE
DEVELOPED TO ENABLE RIGOROUS
TESTING, VERIFICATION TESTING
ENSURED FEASIBILITIES OF THE
DESIGN PROTOTYPE AND PHASE 2 WAS
INTENDED TO CONFIRM AHEAD OF
DESIGN LOCK AND FDA REGULATORY
STUDIES.
PROVIDING IN-KINDS VALIDATION
SERVICES TO PROJECT TEAMS
CREATED EFFICIENCIES FOR ALL
PARTIES.
THE PROJECT TEAMS COULD SET
STRATEGIC MILESTONES TOWARDS
REALLY CLEAR PERFORMANCE GOALS,
WITH FOCUS ON SUBSTANTIALLY
REDUCING DEVELOPMENT TIMES WHILE
ROUTINE VERIFICATION TESTING IN
PHASE 1 PROVIDED TEAMS WITH
EARLIER INDICATIONS OF POTENTIAL
DESIGN ISSUES AND ALLOWED FOR
RAPID AND ITERATIVE OPTIMIZATION
WITH A STRONG EVIDENCE PLACE FOR
TIMELY GO/NO-GO DECISION, VALUE
STUDIES INSTILLED CONFIDENCEE
WHICH REDUCES RISK OF THE LOST
TIME OF HAVING TO REPEAT FDA
STUDIES.
IN SUMMARIZING THE INNOVATION
FUNNEL MODEL, KEY FEATURES WERE
ENGINE THAT DROVE TECHNOLOGY
ACCELERATION, ANY POWERFUL
ENGINE REQUIRES SKILLED DRIVER
TO UNLEASH FULL POTENTIAL AND
WITH TOO MANY TO ACKNOWLEDGE I
WOULD LIKE TO RECOGNIZE THE
VARIED CONTRIBUTIONS OF AN
INCREDIBLE GROUP OF ACCOMPLISHED
AND MOTIVATED INDIVIDUALS,
NUMBERING OVER A THOUSAND ACROSS
PROGRAMS, THIS TYPE OF PROGRAM
DOES NOT FUNCTION WITHOUT HAVING
THE RIGHT PEOPLE IN THE RIGHT
PLACES.
THE INDEPENDENT TEST ASSESSMENT
PROGRAM WAS A DERIVATION OF THE
RAD ACCIDENT OCCURS -- RADx IN
2021, SPAWNED FROM THE DEEP
COLLABORATION BETWEEN RADx AND
FDA THROUGHOUT THE FIRST YEAR OF
THE PANDEMIC.
AND IN AN EFFORT TO
SYSTEMATICALLY STREAMLINE
REGULATORY PROCESS WOULD FOLLOW
BASIC PRINCIPLES OF THE
VALIDATION CENTER, PROVIDING
INDEPENDENT TESTING, UNDER
SUPERVISION OF RADx PERSONNEL
AND NOT INFLUENCE BY SPONSOR
COMPANY, STRUCTURED DATA
COLLECTED AND FORMATTED IN
TEMPLATES, ADDRESSING
REQUIREMENTS FOR REGULATORY
AUTHORIZATION, HAVING PROTOCOLS
AND DATA COLLECTION MANAGED BY
RADx ENSURED FDA RECEIVED
UNVARNISHED AND RELIABLE
INFORMATION TO INFORM ITS
RULING.
IN ADDITION DATA TEMPLATES WERE
DESIGNED TO BE SUBMITTED TO THE
FDA IN REAL TIME, AS REQUIRED
STUDIES WERE COMPLETE.
THIS FORMAT ALLOWED THE FDA
REVIEWSERS TO FAMILIARIZE
THEMSELVES WITH PROJECT EARLIER
IN THE REVIEW PROCESS SO WHEN
THE FINAL DATA WAS COLLECTED AND
SUBMITTED REGULATORY DECISION
COULD BE MADE IN A SHORTER
PERIOD OF TIME AND IN SOME CASES
A FEW SHORT DAYS.
AS ILLUSTRATED ITAP WAS CREATED
TO MOVE QUICKLY THROUGH STAGES
FOR EMERGENCY USE AUTHORIZATION
BY FDA AND THE REQUIREMENTS
ESTABLISHED AN ACCELERATED
PATHWAY, BUT THE FIRST PROJECT
TO BE ACCEPTED INTO ITAP IN THE
FALL OF 2021 THIS WAS AN
OVER-THE-COUNTER RAPID ANTIGEN
TEST FOR COVID-19 RECEIVED EUA
IN 8 WEEKS, SO YOU CAN SEE SOME
ACCOMPLISHMENTS OF ITAP IN THE
BOX ON THE RIGHT, 12 EUAs, 4
BILLION TESTS TO THE U.S.
MARKET.
THIS PAST YEAR 15 AUTHORIZATIONS
FOR COVID, FLU, COMBO TEST FOR
POINT OF CARE AND AT HOME USE,
AND I DID WANT TO HIGHLIGHT THE
HEPATITIS C PROGRAM, RECEIVED
FULL SUPPORT FROM THE FDA, CDC,
NIH PARTNERS, PUSHING THE ITAP
MODEL TO ITS LIMITS TO COMPLETE
THE REGULATORY STUDIES AND
SUBMIT THE PACKAGE IN SIX
MONTHS, THE 510(K) PACKAGE, WITH
A DIFFERENT APPROACH SAVING TIME
AND MONEY.
ITAP REMAINS A CLEAR EXAMPLE,
MOST ESPECIALLY FOR THE AMERICAN
PUBLIC AND PATIENTS THAT RELY ON
TESTS FOR THEIR CARE.
WITH THE FUNNEL AND CAPABILITIES
OF THE POINTED OF CARE
TECHNOLOGIES RESEARCH NETWORK
THE PRIMARY CHALLENGE FOR ME AND
MY NIBIB COLLEAGUES WAS TO
CODIFY UNDERLYING ORGANIZATIONAL
STRUCTURE AND FUNDING STRUCTURES
TO SUSTAIN ONGOING EFFORTS,
DEPICTED ON THE RIGHT YOU CAN
SEE FOUNDATIONAL CONTRACT
VEHICLES CREATED TO SUPPORT KEY
FEATURES OF THE RADx PROCESS
WITH SCALABILITY AND HEAD ROOM
BUILT IN FOR FUTURE ACTIVITIES.
THROUGH PRIMARY CONTRACTS
CONSIST OF THE COORDINATION
CENTER, MANAGED BY CIMIT,
INCLUDING PROCESSES AND
WORKFLOWS, PROPOSAL SUBMISSION,
RISK ASSESSMENT, REVIEW
MEETINGS, ENTREPRENEURIAL
TRAINING, PROJECT MANAGEMENT, AS
WELL AS CRITERIA FOR THE STAGE
GATE.
THE COMMERCIALIZE SESSION
OVERSEES CURATION AND
DEVELOPMENT OF HUMAN RESOURCES,
FORMING THE CORE OF THE SERVICES
EMPLOYED AS PROJECT MANAGER,
REVIEWERS, ADVISORS.
VALIDATION CENTER ANCHORED AT
EMORY PERFORMS TESTING I
PREVIOUSLY DESCRIBED,
CHARACTERIZED AS A DEDICATED AND
MULTI-DISCIPLINARY TEAM, WILLING
TO TAKE ON NEW PROJECTS AND
CHALLENGES AND COMMITTED TO
RADx MISSION OF RAPID
EVALUATION AND RAPID FEEDBACK.
AND AS THEY LIKE TO SAY, THEY
TEST THE TEST.
TOGETHER THESE THREE CENTERS
FORM A STABLE BUT EXTENSIBLE
PLATFORM THAT CAN PROVIDE
TECHNOLOGY ACCELERATION SUPPORT
ACROSS HEALTHCARE SPECTRUM.
UTILIZING THIS INFRASTRUCTURE,
WE'VE SPENT THE PAST FEW YEARS
IMAGINING HOW THE MODEL MIGHT BE
MODIFIED BEYOND THE COVID-19
PANDEMIC, WE'VE WORKED WITH OUR
PARTNERS TO DRIVE DIFFERENT
PROGRAM STRUCTURES, TAILORED TO
THE NEEDS OF THE HEALTHCARE
PROBLEM TO BE ADDRESSED, AND TO
DATE THESE HAVE LED TO THE
CREATION OF MENU OF PROGRAMS IN
THE CENTER OF THIS SLIDE.
ITAP REMAINS ACTIVE, THE TWO
PROGRAMS HAVE BEEN DIRECTED TO
PRIMARILY COMMERCIALIZED
DIAGNOSTIC TESTS, POINT OF CARE
AND OVER THE COUNTER USE.
MED TECH ACCELERATOR PROGRAM
SUPPORTED BY THE BLUEPRINT FOR
NEUROSCIENCE RESEARCH INITIATIVE
RECEIVED RECURRING FUNDING FOR
FOUR YEARS, GOAL OF DEVICES,
DIAGNOSTIC AND THERAPEUTIC, TO
FIRST IN HUMAN TRIALS TO GET TO
THAT VITAL CLINICAL EVALUATION
STAGE.
MED TECH HAS TESTED EXPANSION OF
THE INNOVATION FUNNEL INTO THE
MEDICAL DEVICE SPACE.
AND HOW TO MANAGE A BROADER
SCOPE OF CLINICAL INDICATIONS
AND TECHNOLOGIES.
RADx CHALLENGE WAS DESIGNED TO
UTILIZE PRIZE COMPETITION
AUTHORITY FOR PAYMENT AS OPPOSED
TO TRADITIONAL GRANTS AND
CONTRACTS.
STRUCTURING PRIZE PAYMENTS
AROUND PHASED PROGRAM-WIDE
MILESTONES AND VALIDATION
CRITERIA OFFERS POTENTIAL COST
EFFECTIVE AND LOWER RISK MODEL
FOR RADx AS WE ONLY PAY THE
PROJECTS THAT SUCCESSFULLY
ACHIEVE REQUIREMENTS AT EACH
PHASE.
OTHER BENEFITS INCLUDE LOWER
ADMINISTRATIVE BURDEN ATTRACTING
BROADER POOL OF PROPOSERS, MANY
MAY NOT PARTICIPATE IN NIH
GRANTS AND CONTRACTS, CASH
PRIZEs CAN BE USED BY AWARDEE
FOR ANY PURPOSE, DO NOT REQUIRE
COMPLIANCE WITH NIH AAWARD
POLICIES, STREAMLINED TO HELP
INCENTIVIZE ACCELERATION,
COMMENCE RATE WITH LEVEL OF RISK
BEING BORNE BY THE PROJECT
TEAMS.
AS I DESCRIBED EARLIER, POCTRN
HAS A HISTORY OF PROVIDING
TRANSLATIONAL RESOURCES TO EARLY
STAGE TECHNOLOGIES IN POINT OF
CARE SPACE AND WE AIM TO
CONTINUE TO LEVERAGE THAT
EXPERTISE, IN AREAS OF MUTUAL
INTEREST WITHIN THE NETWORK AND
WITH ADDED RADx SUPPORT,
INITIATIVES CAN BE A PLUG AND
PLAY INTO AN ESTABLISHED
PROCESS, POCTRN HAS ABILITY TO
WORK WITH DEVELOPERS ACROSS THE
SPECTRUM ADDING A PATHWAY FOR
INNOVATIONS THAT MAY NOT HAVE
CLEAR MARKET SIGNALS YET.
AND WITH DEEP CAPABILITIES AND
CLINICAL VALIDATION POCTRN HAS
STRONG TRACK RECORD DRIVING
DE-RISKING OF MILESTONES.
CUSTOMIZING THESE PROGRAMS AS I
LIKE TO DESCRIBE HAS BEEN ABOUT
STOICHIOMETRY, TITRATING THE KEY
FEATURES TO OPTIMIZE --
[ NO AUDIO ]
>> WE'VE LOST YOUR AUDIO AGAIN.
YOU'RE BACK.
>> AM I BACK?
>> YES.
>> APOLOGIES.
BECAUSE OF THE COMPLETED
PROJECTS THAT WE'VE BEEN ABLE TO
AN -- ANALYZE WE COMPARE AGAINT
PROJECT OUTCOMES AND ENABLES US
TO SEE WHICH RESOURCES THE
PROJECTS USE, WHAT QUANTITIES TO
GAIN INSIGHT INTO THINGS LIKE
MINIMUM LEVEL OF PROJECT
MANAGEMENT TO ACHIEVE
ACCELERATION OR UPPER LIMIT OF
SUPPORT, POINTS OF DIMINISHING
RETURNS, THESE DATA CONTINUE TO
SHAPE OUR UNDERSTANDING OF HOW
TO USE THESE TRANSLATIONAL
RESOURCES EFFICIENTLY AND COST
EFFECTIVELY.
AS WE APPROACH PARTNERS TO HELP
ACCELERATE TECHNOLOGIES THAT
ADDRESS NEEDS WE HAVE BUILT
INTAKE PROCESS THAT ADDRESSED
DESIGN CHARACTERISTICS OUTLINED
HERE, THROUGH JOINT DISCUSSIONS
WITH OUR PARTNERS GAIN A CLEAR
UNDERSTANDING OF THE PROBLEM SET
AND SOLUTION REQUIREMENTS AND WE
CAN TAILOR A PROGRAM THAT MEETS
THE GOALS AND EXPECTATIONS AS
WELL AS BUDGET AND TIMELINE.
I WANTED TO RUN THROUGH
INITIATIVES WE'VE COMPLETED OR
STARTED OVER THE PAST FEW YEARS,
ITAP PROGRAM.
WE FOUND A GREAT DEAL OF
TRACTION WITH IN VITRO
DIAGNOSTICS OFFICE AT THE FDA TO
CONTINUE TO SPEED NEEDED
DIAGNOSTICS TO THE MARKET.
I WOULD LIKE TO ALSO THANK AND
HIGHLIGHT OUR FUNDING PARTNERS
ACROSS THE NIH, NIAID, NCI, AS
WELL AS CDC FOR HELPING US BRING
THESE IMPACTFUL TECHNOLOGIES TO
PATIENTS WHO NEED THEM.
WE HAD A PARTNERSHIP WITH OFFICE
OF AIDS RESEARCH AT NIH, WHO
HAVE BEEN VALUED SPONSORS OF
POCTRN NOW PUSHING DEVELOPMENT
OF HIV VIRAL LOAD TESTS.
YOU CAN SEE BLUEPRINT MED TECH
ACCELERATOR ACCOUNTS FOR HALF
THE CENTERS, APPROVED FOR A
SECOND FIVE-YEAR CYCLE WHICH
WE'RE EXCITED ABOUT.
THROUGH THE WOMEN'S HEALTH
INITIATIVES WE HAVE PARTNERED
WITH NICHD, ORWH, WITH THE GATES
FOUNDATION TO CRAFT RADx
CHALLENGES TO ACCELERATE
TECHNOLOGIES FOR MATERNAL
HEALTH, FETAL HEALTH MONITORING,
ENDOMETRIOSIS.
I WISH I HAD MORE TIME TO
DESCRIBE OUTCOMES.
YOU HEARD A BIT FROM BRUCE
EARLIER TODAY.
ONE EXAMPLE OF RADx DEFYING
NIH PROGRAMS, HOW WE INTRODUCE
KEY FEATURES UPSTREAM INTO
RESEARCH-FOCUSED PROGRAMS LIKE
R21, R01, CONCEPT BEING HELP
INVESTIGATORS BETTER ALIGN IDEAS
WITH CLINICAL OR MARKET PULL
DURING MORE NASCENT STAGES.
IF WE PROVIDE EDUCATIONAL
PLANNING AND DE-RISKING WE MIGHT
BE ABLE TO INCREASE YIELD OF
PROJECTS THAT PURSUE TRANSLATION
AND HOPEFULLY SUCCESSFUL
COMMERCIALIZATION OF THEIR
TECHNOLOGIES AND ONE EARLY
EXPERIMENT IN THIS VAIN IS --
[ NO AUDIO ]
>> REPEAT THAT SLIDE.
>> I'LL GO BACK, APOLOGIES.
ONE EXPERIMENT IS THE
BIOMATERIALS NETWORK, WHICH WILL
UTILIZE RADx COMMERCIALIZATION
SERVICES TO HELP TECHNOLOGY
DEVELOPMENT PROJECTS IDENTIFY
BARRIERS TO TRANSLATION AND
DESIRE HERE IS REALLY TO BETTER
PRIME BIOMATERIALS PROJECTS WITH
PROJECTS THAT DEMONSTRATE
DEFENSIBLE VALUE PROPOSITION FOR
CLINICAL USE.
RISK ASSESSMENT, TRAINING,
WRAPAROUND SUPPORT MIGHT HELP
ACCELERATE RESEARCH THAT'S AIMED
AT INNOVATIVE TECHNOLOGIES AND
WE ARE HOPEFUL FOR A SUCCESSFUL
PILOT TO MODEL FUTURE EFFORTS.
SO JUST TO LEAVE YOU WITH FINAL
THOUGHTS AND CONSIDERATIONS,
HERE'S THE VALUE PROPOSITION
WE'VE LAID OUT.
WE KNOW THERE ARE NUMEROUS
TRANSLATIONAL RESEARCH PROGRAMS
OUT THERE, ALL ENGAGING IN SOME
VARIATION OF THE ACTIVITIES I
DESCRIBED, AND WE'RE SUPPORTIVE
TO BRING NEW TECHNOLOGIES TO
PATIENTS.
WE FEEL, HOWEVER, THAT THROUGH
THE EXPERIENCE OF THE PANDEMIC
THE RADx INNOVATION FUNNEL WAS
PRESSURE TESTED, AND BATTLE
HARDENED, AS A MODEL FOR RADICAL
TECHNOLOGY ACCELERATION AND WE
HAVE A GREAT TEAM, CAPABLE OF
EXECUTING ON TIME TIMELINES.
IN-KIND SERVICES CAN GENERATE
MORE VALUE TO PROJECTS THAN
FUNDING ALONE.
THE SUPPORT GUIDANCE AND
MENTORSHIP CAN HELP AVOID
MISTAKES, ADDING CREDIBILITY
WHEN SEEKING FUTURE INVESTMENT.
THE MENU AFFORDS GREAT
FLEXIBILITY ACCOUNTING FOR NEEDS
ACROSS THE AREAS, SCALABILITY OF
THE PLATFORM MEANS ACCELERATION
CAN BE ACHIEVED ON ANY BUDGET
WHETHER SUPPORTING DOZENS OF
PROJECTS THROUGH ITAP OR TWO ON
FOUR TEAMS THROUGH A CHALLENGE.
AND PARTNERSHIPS INSIDE AND
OUTSIDE GOVERNMENT ARE KEY, WILL
ENABLE TO EXPAND THE SCOPE OF
IMPACT AS YOU'VE SEEN, WE'VE LEE
LIED ON WORTH OF MOUTH AND
OUTREACH.
AN UPON POINT FROM THE NIBIB
PERSPECTIVE OUR RADx
APPLICANTS ARE TECHNOLOGY
DEVELOPERS, THEY COME FROM
ENGINEERING AND IMAGING
COMMUNITIES, AND WE FEEL RADx
HAS BEEN A MEDIUM FROM WHICH WE
WITH LEVERAGE THIS MASSIVE
SOURCE OF TALENT TO DELIVER MORE
SOLUTIONS TO EMERGING AND
FORMIDABLE PUBLIC HEALTH
PROBLEMS.
ON THAT NOTE I WANTED TO ECHO
AGAIN THE SUCCESS OF THESE
PROGRAMS IS ABOUT THE, ONE FINAL
THANKS TO THOSE WHO WORKED WITH
US FOR FIVE YEARS, THE CREDIT
FOR THIS SUCCESS NEEDS TO BE
SPREAD FAR AND WIDE.
STEVE AND RAY SPEARHEADED WITH
CONTRIBUTIONS FROM ALL OF OUR
COLLABORATORS, AND WITH THAT I
APPRECIATE YOUR TIME AND
ATTENTION AND LOOK FORWARD TO
FURTHER DISCUSSION.
THANK YOU.
>> FANTASTIC.
THANK YOU, TODD, FOR YOUR
PRESENTATION.
WE'LL TAKE YOUR SLIDES DOWN AND
OPEN THE FLOOR FOR QUESTIONS.
ANOTHER TOUR DE FORCE.
BRUCE?
>> LET ME ADD ONE MORE
INTERESTING POINT TO WHAT TODD'S
FANTASTIC PRESENTATION THAT
BROKE ALL THIS DOWN, DEMYSTIFIED
THE PROCESS IN RADx AND
EXTENSIBILITY TO SO MANY OTHER
CONCEPTS AND PROJECTS.
SO A HUGE BENEFIT TO US, TODD
MENTIONED CONTRACTING OFFICE AT
NHLBI, AND OUR EXECUTIVE OFFICER
LED THAT, AND WORKED THROUGH ALL
THESE INTENSIVE MOMENTS WITH US
AND HELPED REALLY FIGURE OUT THE
LOGISTICS OF ISSUING LARGE
CONTRACTS, UNPRECEDENTED AT THE
NIH AND AMAZINGLY SHORT PERIOD
OF TIME.
SO, ANOTHER BENEFIT, TODD, ALL
OF THIS INTRODUCED US TO ANNE,
AND WE RECRUITED ANN AS OUR
EXECUTIVE OFFICER, SELFISH BUT
THAT'S BEEN SUCH A GAME CHANGER
FOR US.
SO NOT ONLY ALL THE PEOPLE THAT
WE WORKED WITH, SO
EXTRAORDINARY, EXTRAORDINARILY
GENEROUS AND CONTRIBUTING ALL
ACROSS THE NIH, BUT AS YOU
MENTIONED, NHLBI CO-ACT AND OUR
PATHWAY TO RECRUITING ANN TO
NIBIB AND THAT POINT ABOUT ALL
THE PEOPLE ENGAGED, ALL ACROSS
THE NIH, SO THIS WAY OF THINKING
IS NOW -- WE HAVE TO THIS IN
DEVELOPMENT, PROGRAM OFFICERS
ARE ENGAGED IN THIS DEVELOPMENT
ALL THE TIME.
WE HAVE VARIOUS THINGS THAT ARE
IN PROGRESS, UP IN THE AIR, IN
DISCUSSION.
BUT THAT MECHANISM OF REACHING
OUT IS HAVING AN IMPACT, EVEN AS
PROGRAMS ARE BEING DEVELOPED,
AND FOR EXAMPLE WE'RE IN
DISCUSSIONS WITH PRIMED A.I.
ABOUT ELEMENTS OF THAT PROGRAM
POSSIBLY IF WE COULD PENETRATE
COMMON FUND WITH SOME ELEMENTS
OF A COMMON FUND PROGRAM
CAPTURED THROUGH THE INNOVATION
FUNNEL WE COULD BE LASTING WAY
TRANSFORMATIONAL ACROSS MANY
SECTORS, ACROSS THE NIH.
WHICH IS PART OF OUR GOAL, AND
THEN OBVIOUS BENEFITS AS TODD
LAID OUT ARE IMPRESSIVE.
I'LL STOP THERE FROM THE
PERSONAL BENEFIT POINT OF VIEW
AND THE IMPACT ON OUR COLLEAGUES
ACROSS NIH.
>> THANKS.
>> THANK YOU, TODD.
THAT WAS REALLY FANTASTIC.
THANK YOU SO MUCH.
SO BEING AN ALUM OF THE NSFI
CORE PROGRAM, I APPRECIATE THE
TREMENDOUS KIND OF SCOPE OF
EVERYTHING, AND YOU REALLY HAVE
THIS GREAT OPPORTUNITY.
I HAVE TWO QUESTIONS OR
COMMENTS.
ONE HAS TO DO WITH THE QUESTION
OF HOW MUCH I THINK YOU AT
NIBIB, YOU HAVE AN IDEA OF
YOU'RE ABLE TO SEE ALL OF THE
DIFFERENT PROJECTS, SO YOU CAN
COMPARE AND CONTRAST BECAUSE
USUALLY WHAT THE COMPANIES I
WOULD GUESS HAVE COMPETITIVE,
YOU KNOW, LIKE MAYBE THEY DON'T
WANT TO SHARE THAT MUCH
INFORMATION OR I.P.
FIRST QUESTION IS RELATED TO,
YOU KNOW, COMMONALITIES,
BARRIERS THEY FIND LET'S SAY FOR
REGULATION FOR FDA, YOU
MENTIONED SOME THINGS WHERE YOU
BROKE IT DOWN AND SAID YOU COULD
ACCELERATE BY READING IN THE FDA
EARLY ON, THAT'S ONE EXAMPLE.
BUT WONDERING IF THERE WAS MORE
STRUCTURAL ELEMENTS THAT YOU
FOUND THAT WERE COMMON THAT
REALLY REQUIRED A POLICY CHANGE
SO THAT'S ONE QUESTION.
SECONDS QUESTION THIS IS GREAT
FOR DIAGNOSTICS BUT I'M THINKING
ABOUT SOMETHING LIKE THERAPIES
MORE, WHICH REQUIRE LET'S SAY
MORE INVOLVED CLINICAL TRIALS,
WHICH ARE MUCH MORE COMPLICATED,
MUCH MORE EXPENSIVE, WONDERING
IF YOUR THOUGHT OF EXPANDING OUT
TO THAT ASPECT AS WELL, TWO
QUESTIONS.
>> SURE, YES.
THANK YOU FOR THOSE QUESTIONS.
YEAH, THERE'S A NUMBER OF WAYS
TO ANSWER THE FIRST QUESTION.
WE DID FIND A LOT OF ECONOMIES
OF SCALE WHEN YOU'RE TARGETING
ONE CLINICAL AREA.
AND HAVE A NUMBER OF COMPETITORS
COMPETING IN THE SAME SPACE,
THERE'S A HOST OF STRUCTURES
THROUGHOUT THE PROGRAM TO MAKE
SURE INFORMATION IS PROTECTED IN
THAT WAY.
AND I WON'T GO INTO DETAIL ON
THAT BUT, YES, THE TWO-WAY
COMMUNICATION WITH FDA DID
INFLUENCE POLICY BOTH WITHIN NIH
AND THE FDA AS WE LEARNED MORE,
AS LARGELY BECAUSE THE PANDEMIC
WAS A DYNAMIC SITUATION, ALL
LEARNING ON THE FLY.
BUT FEED FORWARD INFORMATION
ABOUT WHAT PROJECTS WERE IN THE
PIPELINE, WHAT THE FDA WAS
LIKELY TO SEE IN A A FEW MONTH,
SEEING CHALLENGES, ISSUES WITH
TESTING, ASSAYS, DEVICES, TO GET
THAT IN FRONT OF THE FDA FOR
THEIR CONSIDERATION, ALSO PLAN
VARIOUS STUDIES IN OTHER THINGS
THAT MIGHT BE NECESSARY TO
UNLOCK SOME OF THAT NEW
INFORMATION.
YES, THERE WAS A LOT OF
COLLABORATION ENSURING THAT
HAPPENS ON A TARGETED NARROW
PATH AS FAR AS SCOPE AND
RESOURCES DEDICATED TO THAT.
THAT'S PART OF THE ACCELERATION
ASPECT OF IT.
SORRY, THE SECOND QUESTION WAS
--
>> CLINICAL TRIALS.
THE SECOND QUESTION WAS MORE
LIKE --
>> THERAPEUTICS.
>> DIAGNOSTICS, WITH THERAPY, A
LOT OF COMPANIES ACTUALLY FALL
FLAT BECAUSE THE CLINICAL TRIAL
IS SO EXPENSIVE, SO MANY ISSUES,
IT'S ANOTHER CHALLENGE.
I'M WONDERING IT SEEMS LIKE THAT
IS ALSO RIPE FOR THIS KIND OF
APPROACH TO REALLY, YOU KNOW,
HAVE CHECKLISTS AND THINGS LIKE
YOU SAID.
I REALLY LOVE MORE SYSTEMATIC
APPROACH I GUESS, WONDERING IF
YOU THOUGHT ABOUT THAT LIKE
GOING BEYOND DIAGNOSTICS.
>> WE BRANCHED OUT, IN OTHER
TIMES OF DEVICES.
TO DATE ALL IN THE MEDICAL
DEVICE SPACE, CDRH SPACE AT THE
FDA.
WE HAVEN'T PUT A LOT OF THOUGHT
IN THERAPEUTICS YET.
WE BELIEVE THIS IS A PLATFORM,
AS WAS MENTIONED, THESE VARIOUS
COMPONENTS COULD BE USED FOR ANY
TYPE OF PROJECT, ACCELERATE
PROJECTS, MAY BE ON DIFFERENT
TIME SCALES LIKE YOU MENTIONED,
IF THE TRIALS ARE MORE COMPLEX
AND EXTENSIVE BUT I THINK AS
ENGINEERS WHO LOVE TO SOLVE
PROBLEMS WE WOULDN'T SHY AWAY
AND WOULD LOVE TO TACKLE THAT IN
THE FUTURE.
>> WITH SORT OF PROGRESS IN
BIOMATERIALS, BIOMANUFACTURING,
AND THE SORT OF REDUCTION TO
PRACTICE OF BESPOKE KIND OF THE
BIG EXAMPLES ARE CAR T OR OTHER
TYPES OF CELL CONJUGATES THAT
CAN BE FASHIONED IN A CUSTOMER
BESPOKE WAY FROM INDIVIDUAL
PATIENTS, INCREASINGLY SORT OF
WORKED OUT IN EFFICIENT AND
REPRODUCIBLE FORMATS IN
HOSPITALS, SO THESE THINGS ARE
BEING DELIVERED IN MEDICAL
CENTERS FOR -- AND YOU CAN NAME
A COUPLE, I'M THINKING OF BAYLOR
IS INVOLVED, MAYBE TEXAS
METHODIST, I'VE SEEN
PRESENTATIONS FROM YOUR
COLLEAGUES, JOYCE, THAT SUGGEST
SOME THINGS ARE READY TO ROLL
OUT.
>> YES.
>> IN BESPOKE DELIVERY PLATFORMS
FOR INDIVIDUAL PATIENTS.
USING GENERALIZABLE PRINCIPLES.
AND SO I THINK THAT'S WHERE THE
FRONTIER COMES.
WE LOOK TO YOU AND YOUR
COLLEAGUES FOR GUIDANCE ON THAT
BECAUSE IN ALL OF THE DISCUSSION
ABOUT OFFSHORING OR ONSHORING WE
CAN'T KEEP OUR EYES OFF THE
BALL.
THERE'S STUFF HAPPENING IN FRONT
OF US BIOMANUFACTURING GROWTH
AND POTENTIAL AND OPPORTUNITY,
AND, YOU KNOW, IF WE OBSESS OVER
ALL THE OLD THINGS WE'RE GOING
TO LOSE THE NEW INNOVATION
CUTTING EDGE THINGS.
WE ACTUALLY REALLY NEED TO COME
TOGETHER AS A COMMUNITY, AS A
COUNCIL, TO REALLY IDENTIFY
THOSE OPPORTUNITIES.
>> WHAT COMES TO MIND IS THE
DIGITAL TWIN OR PHANTOMS, I
GUESS TALKING ABOUT PHANTOM
RESOURCE FOR IMAGING, A.I. WOULD
COME IN TO THAT AS WELL.
PEOPLE ALREADY ARE DOING THAT
WITH 4D, 4D-PRINTED OR KIND OF
DIGITAL TWIN THINGS.
I LOVE HOW YOU ADDED
BIOMATERIALS, FANTASTIC TYING TO
R01 AND R21.
>> I WASN'T INVOLVED WITH THIS.
I DON'T HAVE THE DETAILS OF WHAT
HAPPENED WITH COVID DIRECTLY,
BUT THE INDEPENDENT TEST
ASSESSMENT PROGRAM IS REALLY A
BIG THING FOR THE AGENCY TO PUT
CONSISTENCY IN HOW THE
EVALUATIONS WITH DONE, HAVING IT
DONE BY AN INDEPENDENT GROUP HAS
VALUE.
DOING EXPECT COMPARISONS, A.I.
AND SO FORTH, 510(K), DIRECT
COMPARISONS CAN MINIMIZE THE
EXTENT OF DATA NEEDED, NUMBER OF
PATIENTS, SO THERE'S A LOT OF
VALUE.
IT HELPS INDUSTRY TO BE
CONSISTENT WITH WHAT THEY ARE
DOING SO WE DON'TS HAVE TO GET
FIVE THINGS AND FIX ON THE BACK
END.
THAT PART FROM THE AGENCY IS ONE
OF THE HUGE ADVANTAGES.
CERTAINLY CAN BE REPLICATED IN
OTHER AREAS BEYOND JUST THESE
TYPES OF DIAGNOSTIC TESTS BUT
MOVE INTO A.I., POTENTIALLY INTO
SOME, AT LEAST IN OUR CASE,
DEVICE THERAPEUTICS AS WELL
POTENTIALLY.
IT'S REALLY -- THAT PART IS
USEFUL FOR FDA.
>> WE NEED YOUR HELP.
EVERYONE WE TALKED TO AT FDA IS
VERY EXCITED AND RECEPTIVE BUT
WE'RE ALSO IN A MOMENT WHERE
EVERYONE IS A LITTLE BIT SORT OF
SHAKEN UP, JARRED, MOVED AWAY
FROM OUR ORIGINAL TRAJECTORIES,
YOU KNOW, PERHAPS, THAT WE
THOUGHT WERE QUITE CLEAR BACK IN
2024.
I THINK WE JUST HAVE TO WORK
HARD TO GET BACK ON TO THOSE AND
TAKE ADVANTAGE OF THESE
SUCCESSES AND CONTINUE TO MOVE
FORWARD.
KIND OF PUSH THE ENVELOPE.
IT'S INTERESTING THAT OUR
CUSTOMERS, TODD WITH TALK TO
THIS, ARE BIG LIKE WE HAVE ALL
THE BIG COMPANIES WITH STRONG
REGULATORY GROUPS WANTING TO
WORK IN THIS AS WELL AS SMALL
ONES.
SO I THINK IT'S A TESTAMENT TO
THE VALUE ADD THAT IT BRINGS,
YOU KNOW, EVEN TO WELL RESOURCED
ORGANIZATIONS, MATURE, YOU KNOW,
FINDING THAT THERE'S ENORMOUS
BENEFIT TO THAT INDEPENDENT
APPROACH THAT BOTH THE FDA AND
COMMERCIAL ENTITY REALLY LIKE.
>> YEAH, AND JUST GENERALLY THE
FDA HAS ALSO GONE THROUGH
TRANSITIONS AND DOWNSIZING AND
OTHER THINGS.
SO WE ARE I THINK GETTING A
LITTLE BIT MORE INTO WHATEVER
THE NEW NORMAL IS AS WE MOVE
FORWARD.
OPPORTUNITIES ARE THINGS AS WE
MOVE FORWARD SHOULD BE ABLE TO
AT LEAST TALK ABOUT IT MORE IN
DETAIL AND MOVE FORWARD WITH.
>> RAPHAEL?
>> CONGRATULATIONS.
FORMIDABLE ACCOMPLISHMENT.
IT'S GREAT.
WHAT I ALSO SEE AS IN ADDITION
TO ALL THE THINGS SAID, THAT
PROGRAMS LIKE THIS CHANGE, HAVE
THE POTENTIAL TO CHANGE THE
PUBLIC IMAGE THAT THE INVESTMENT
IN NIH HAS BOTH LONG TERM AND
SHORT TERM RETURNS.
AND THIS KIND OF A THING, NIH I
DON'T THINK ANYONE THINKS OF AS
A TECHNOLOGY ACCELERATOR.
BUT I THINK HAVING THAT AS A
PART OF IT REALLY HELPS.
AND, AGAIN, CONGRATULATIONS,
GREAT PRESENTATION.
>> APPRECIATE THAT.
THANK YOU, RAPHAEL.
>> SO RAPHAEL YOU'RE STIMULATING
A SMALL OBSCURE FACT, ANN HAS
WORKED WITH ME SINCE I CAME, ONE
OF THE FIRST QUESTIONS I ASKED,
HOW MUCH DO ALL THE OTHER
INSTITUTES INVEST IN
BIOENGINEERING?
I FEEL LIKE NIH IS A PRETTY
STRONG TECHNOLOGY AGENCY BUT
NOBODY, YOU KNOW, PEOPLE DON'T
THINK OF IT LIKE THAT.
IT'S BIOLOGY.
IT'S MEDICINE.
IT'S PUBLIC HEALTH.
BUT TODD?
THE ANSWER?
>> YOUR QUESTION, DO YOU
REMEMBER?
I THINK IN 2019, WELL, ANYWAY,
2023 THE MOST RECENT DATA FROM
YOUR TEAM, FROM JENNIFER, IS 14%
OF THE NIH BUDGET.
$7 BILLION ALL ACROSS THE
INSTITUTES --
[CROSSTALK]
>> THAT'S AMAZING.
>> YEAH.
>> TODD AND HIS TEAM ARE IT'S
CONSERVATORS OF THAT STATISTIC.
I REFUSE TO ACCEPT IF IT GOES
DOWN.
>> OKAY.
THANK YOU, TODD.
I'M SORRY, WILBUR?
>> YEAH, THANK YOU.
TODD, IT'S GREAT TO SEE YOUR
PRESENTATION ON KIND OF THE FLIP
SIDE OF THINGS.
SO, A COUPLE OF POINTS FOR YOU
AND BRUCE THAT FROM OUR
PERSPECTIVE, WHEN I TALK ABOUT
RADx SOMETIMES I GET PUSHBACK.
YEAH, SURE, IT COSTS A BAJILLION
CZARS, OF COURSE YOU CAN DO COOL
THINGS WITH THAT.
I THINK WHAT WE LEARNED WITH
RADx A LOT OF TENETS CAN BE
SCALED DOWN AND STILL BE VERY
EFFECTIVE AND VALUABLE.
AS YOU KNOW YOU'VE TALKED ABOUT
SOME OTHER PROGRAMS.
THEY DON'T HAVE SPINOFF
PROGRAMS, DON'T HAVE THE BUDGET
THE ORIGINAL RADX-TECH PROGRAM
WITH BUT YOU'RE STILL ABLE TO
MAINTAIN A LOT OF THE PROCESSES
AND A LOT OF THE KEY PRINCIPLES.
AND THEY BRING A LOT OF VALUE.
WE AT EMORY, WE'RE APPLYING A
LOT OF THESE VERIFICATION MODELS
FOR EXAMPLE WHEN OUR DEAN WANTS
TO INVEST IN INNOVATION
PROJECTS, SO WE SAY, OKAY, LET'S
INSERT A TECHNOLOGY VERIFICATION
STEP INTO IT BECAUSE IT CAN HELP
YOU DECIDE WHAT TO FUND, WHAT TO
RE-UP, SO THAT'S BEEN REALLY
IMPORTANT.
IT'S VERY COST EFFECTIVE.
THAT'S THE SECOND POINT IN THE
MIDST OF THIS DISCUSSION ABOUT
NIH BEING MORE EFFICIENT AND SO
FORTH.
I THINK THIS COULD BE PART OF
IT, RIGHT?
A LOT OF WHAT WE DO HERE IS
ACTUALLY IMPROVING EFFICIENCY,
IMPROVING COST EFFECTIVENESS, IN
TERMS OF, BRUCE, YOU USED THAT
PHRASE, FORCING FAST FAILURE
THAT CREATES QUITE A BIT OF
VALUE, THINGS WE CAN REMEMBER
AND MOVING FORWARD CAN BE SCALED
DOWN OR UP AS NEEDED.
>> YEAH, THANK YOU, WILBUR.
EXCELLENT POINT.
I TRIED TO MAKE THAT CLEANLY AT
THE END AS FAR AS THIS
UNDERSTANDING THAT THE IN-KIND
SUPPORT, SOME PROCESSES, WHAT
DRIVES THE ACCELERATION, SO YOU
CAN THINK OF IT AS, YES, YOU
NEED MORE RESOURCES TO SUPPORT
ALL THESE ACTIVITIES BUT IF YOU
THINK OF LET'S SAY YOU GIVE FIVE
MILLION DOLLAR GRANT TO A TEAM
VERSUS ONE MILLION AND SPENDING
FOUR MILLION ON OTHER RESOURCES,
CAN YOU GO FASTER AND FARTHER
WITH THAT TYPE OF MODEL.
THAT'S WHAT WE'VE SEEN.
WE'VE WORKED PART OF THIS
OPTIMIZATION OF THESE DIFFERENT
MECHANISMS WITHIN RADx, WOULD
STRIVE TO DO THAT, DRIVE THE
COST OF THE OVERALL
INFRASTRUCTURE DOWN BUT STILL
MAINTAINING SOME LEVEL OF
ACCELERATION SO WE FEEL LIKE
WE'VE DONE THAT AND, AGAIN, WE
CAN OFFER PRETTY SCALABLE
SOLUTIONS TO REALLY ANY PROBLEM.
THANK YOU.
>> LAST CALL?
ALL RIGHT.
DO YOU HAVE ANOTHER QUESTION OR
IS YOUR HAND UP FROM BEFORE?
I THINK YOU'RE TALKING?
>> HE'S ON MUTE.
>> I APOLOGIZE.
>> NO WORRIES.
JUST WANTED TO MAKE SURE WE GOT
YOU IF YOU DO.
OKAY.
SO, THANK YOU, TODD.
AND APPRECIATE YOU COMING HERE
TODAY TO TALK TO US.
SO, THIS CONCLUDES WITH THE OPEN
SESSION AGENDA.
SO, AS WE START TO WRAP UP I'D
LIKE TO THANK OUR COUNCIL
MEMBERS FOR REALLY THOUGHTFUL
DISCUSSION TODAY.
ENGAGING BRUCE AND OTHER
PRESENTERS.
FOR THOSE OF YOU WATCHING THE
VIDEOCAST WE HOPE TO SEE YOU IN
SEPTEMBER.
BEFORE WE TRANSITION TO THE
CLOSED SESSION, I'D LIKE TO
ACKNOWLEDGE THE EFFORTS OF ALL
OF THE STAFF THAT WERE INVOLVED
IN MAKING THIS WORK TODAY.
AS YOU HEARD BRUCE TALK ABOUT,
ALL THE HELP ORGANIZING EVERY
DETAIL OF TODAY'S MEETING AND
WORKING TO GET EVERYONE
APPOINTED SO WE HAVE SUCH A
ROBUST GROUP OF PEOPLE WITH US
TODAY AND I'VE SHARED WITHOUT
BOTH OF THEM WE WOULD BE
COMPLETELY LOST.
I'D LIKE TO ACKNOWLEDGE THE I.T.
AND VIDEOCAST SUPPORT WE'VE HAD
TODAY.
THEY SPEND A LOT OF TIME IN
ADVANCE PREPARING AND DOING DRY
RUNS TO MAKE SURE EVERYTHING
RUNS SMOOTHLY, BUT THEY ARE
ALWAYS THERE QUICKLY TO RESOLVE
ISSUES THAT COME UP.
WE APPRECIATE THEIR HELP.
ALSO AS BRUCE SAID I'D LIKE TO
ACKNOWLEDGE THE TREMENDOUS
EFFORTS OF PUTTING TOGETHER
BRUCE'S SLIDES, A MASSIVE
COORDINATION EFFORT AND THEY
WORK ON SHORT DEADLINES AND DO A
TREMENDOUS JOB.
SO THANK YOU TO BOTH OF YOU FOR
DOING THAT.
LASTLY I I THANK DAVID FOR
COACHING ME THROUGH PREPARING
FOR TODAY.
WE HAD THIS WORKED OUT FOR A FEW
MONTHS AGO BUT, YOU KNOW, WE'LL
TAKE IT NOW.
I FEEL MUCH MORE BATTLE HARDENED
SINCE THEN.
SO WITH THAT, WE ARE READY TO
ADJOURN BEFORE EVERYBODY SIGNS
OFF WE'LL BEGIN CLOSED SESSION,
WE'LL TAKE A BRIEF TEN-MINUTE
BREAK, SO BY THE TIME WE'RE DONE
HERE 4:30, WE'LL REJOIN AT 4: 40
WITH A NEW TEAMS LINK YOU'LL
JOIN ON THAT, AND SO WE'LL SEE
YOU SHORTLY.
WITH THAT, THE OPEN SESSION OF
THE 68 MEETING OF THE NIBIB
ADVISORY COUNCIL IS ADJOURNED.
SO WE'LL SEE YOU SOON.
THANK YOU, EVERYONE.
[END OF PROGRAM]